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MEDTRONIC IRELAND ARES ANTIBIOTIC-IMPREGNATED PERITONEAL CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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| Model Number 93092 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Diarrhea (1811); Fatigue (1849); Headache (1880); Nausea (1970); Vertigo (2134); Blurred Vision (2137); Visual Impairment (2138)
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| Event Date 03/27/2021 |
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Event Type
Injury
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Event Description
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It was reported that an office visit on (b)(6) 2020, the patient presented post-op with headaches worse when sitting up.Patient's shunt was adjusted from 1.5 to 1.0.Office visit on (b)(6) 2021: patient present for shunt adjustment due to continued headaches.The patient's shunt setting confirmed at 1.0 and was adjusted to 0.5.Office visit (b)(6)2021: the patient is not doing well with the new setting and is having excruciating headaches.Office visit (b)(6) 2021: patient presents today for a shunt adjustment s/p lps removal and replacement with codman valve on (b)(6) 2021.Patient states that she is doing great.She notes an improvement in headaches.She states that it still hurts to move her eyes, but this pain has slightly improved since the replacement with the codman valve.She still complains of occasional blurry vision and states that she "cannot focus ".At surgery she was se t at 3.0, and is eager to go to a lower setting of 2.0.Patient has resumed taking lasix 40 mg twice daily.Office visit (b)(6) 2021: patient is a (b)(6) female with past medical history of pseudotumor cerebri presenting today for 1 month follow-up and shunt adjustment.Patient complains of worsening symptoms, increase in headaches, vertigo, nausea and fatigue.Overall, she feels unwell.Office visit (b)(6) 2021: patient is a (b)(6) female with past medical history of pseudotumor cerebri presenting today for wound check.She is s/p lp shunt revision on (b)(6).She complains of abdominal pain and bleeding from incision site.Patient was going to go to (b)(6) er but we redirected her to the office.She states that her has are much better after the lp shunt revision.Denies fevers, chills, nausea/vomiting.Office visit (b)(6) 2021: patient is a (b)(6) f with pmh of pseudotumor cerebri and chiari malformation presenting today to review stat ct abdomen.Patient has been complaining of sharp/stabbing abdominal pain since revision of lp shunt on (b)(6) 2021.She states that the abdominal pain is localized to below the incision site.In addition, she complains of high pressure headaches, nausea, and forgetfulness.She is still completing her post-op antibiotics (clindamycin).Patient's shunt was adjusted from 1.5 to 0.5.Office visit (b)(6) 2021: patient is a (b)(6) female with past medical history of pseudotumor cerebri and chiari malformation presenting today for postop visit (s/p re-exploration and connection of lp shunt (b)(6) 2021).At last visit, patient complained of sharp abdominal pain and worsening headaches.Ct abdomen was reviewed and the lp shunt was intact.Patient shunt was adjusted from 1.50 to 0.5.Today, patient is doing better but still complains of sharp abdominal pain around the incision site.In addition, she is having some has throughout the day when she is upright and moving around.She finds some relief with lying prone.She would like to stay at her current setting and follow-up in a few weeks to reassess symptoms.Office visit (b)(6) 2021: patient is a (b)(6) female with past medical history of pseudotumor cerebri and chiari malformation presenting today for shunt adjustment (s/p re-exploration and connection of lp shunt (b)(6) 2021).On (b)(6) 2021, her shunt was confirmed at 0.5 and kept at that setting - per patient request.Patient has continued to have has that are worse throughout the day and better when lying down.Has are generalized and make her feel tired/fatigued.Patient saw dr.(b)(6), neuro-ophthalmologist, who recommended changing shunt to 1.0 due to low pressure has.Office visit (b)(6) 2021: patient is a (b)(6)female with past medical history of benign intracranial hypertension and chiari malformation presenting today for 2 week follow-up (s/p re-exploration and connection of lp shunt (b)(6) 2021).Patient continued to complain of sharp abdominal pain in her right and left flank region.Today, she also complains of headaches that are worse with lying down.Occasionally she experiences occipital has, she states that they occur randomly throughout the day.She believes that she is under shunting since has worsen when she bends over and lay down.She also complains of double vision, both eyes but worse in the left.Her current setting was confirmed at 1.0 at lv.She sees dr.(b)(6) (b)(6) 2021.Telehealth (b)(6) 2021: patient is a (b)(6) female with past medical history of benign intracranial hypertension and chiari malformation presenting today for 2 week telephone follow-up (s/p re-exploration and connection of lp shunt (b)(6) 2021).She continues to experience sharp abdominal pains, occasionally worsened after eating.The abdominal pain worsens her has.Has are described as sharp pain behind the eyes.She has had good days and bad days.She will be seeing dr.(b)(6) next week (b)(6) 2021.She has been walking her dog 3x/week, trying to increase her physical activity as needed.Office visit (b)(6)2021: patient is a (b)(6)female with past medical history of benign intracranial hypertension and chiari malformation presenting today for follow-up requested by patient (s/p re-exploration and connection of lp shunt (b)(6) 2021).Patient continues to complain of sharp right flank abdominal pain.She states that the pain is unbearable.She also feels "sick to her stomach" and complains of a dull aching pain in her upper mid-section.She states that she has horrible diarrhea and feels constantly hot.Patient states that she feels like she has an "infection".She also complains of constant headaches, regardless of position.She hasn't been as active or walking her dog as much.She has been exhausted and more depressed than normal.Patient recently saw dr.(b)(6) who believes patient could have an abscess in her abdomen.Per patient, her eye pressure is slightly decreased, as checked by dr.(b)(6).Office visit (b)(6) 2021: patient is a (b)(6) female with past medical history of benign intracranial hypertension and chiari malformation presenting today for follow-up requested by patient (s/p revision of lp shunt and removal of abdominal adhesion (b)(6) 2021).Shortly after surgery, patient notes improvement in her abdominal pain.Has have decreased.Still experiencing sharp pain over incision site.However, she is no longer the pain in her diaphragm or left upper quadrant.However, further information provided stated that the valve was explanted on (b)(6) 2021.It was indicated that the patient had adhesions due to the multiple surgeries.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information was added to the event description.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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In a conversation with medtronic's outside counsel, a patient alleged the following: they claim that for each of the shunts that they had since (b)(6) 2020 that they had both under-shunting and unintended shunt adjustments.They claim that their medical records will document that the settings programmed would change on their own and that their doctor would end up using imaging to try to figure out what was going on.They stated that their doctor took out the first one and replaced it with a vp shunt which is not designed for use in the abdominal area.This did not work.They claim a second set of issues: in (b)(6) 2021, they had a new medtronic lp shunt placed, but the doctor did not replace the lumbar shunt.During (b)(6) they had the multiple episodes of the valve coming off the connector.They claim it was the connector that was sharp and causing their internal damage even when the catheter was reapplied.They stated that even after the (b)(6) 2021 surgery where their doctor protected the attachment they were having pain and the shunt was still adjusting improperly and under-shunting.They stated in the (b)(6) 2021 surgery to move the device, they found adhesions that they claim were due to the movement of the sharp connector.They stated that they had the device from the (b)(6) 2021 procedures.They said it was explanted in (b)(6) 2021 with additional adhesions found.They now are back to the straight self-adjusting original shunt set up.They claim they had a surgery in january for adhesions and that they are minimal now.To date, the patient has refused to return the device in their possession for analysis.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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(b)(6) 2020 preop diagnosis: malfunctioning lumboperitoneal shunt spetzler martin type benign intracranial hypertension procedures: 1.Implantation of medtronic strata lumbo-peritoneal shunt set at 1.5 2.Removal of existing peritoneal end of lumboperitoneal shunt: 3.Lapathscopic implant of peritoneal catheter the patient tolerated the procedure well there were no complications the patient returned to the recovery room in stable condition.Ov (b)(6) 2020: patient presents post -op with headaches worse when sitting up.Medtronic lp shunt adjusted from 1.5 to 1.0 setting.Ov (b)(6) 2021: patient present for shunt adjustment due to continued headaches.Medtronic [p shunt confirmed at 1.0 setting.] medtronic lp shunt adjusted from 1.0 to 0.5 setting, shunt located approximately 5 cm away medially and 2 cm rostral at a 20 degree angle from incision¿ lp shunt codman (valve slightly above and medial to incision; hold device on an angle facing caudally) ov (b)(6) 2021: the patient is not doing well with the new setting and is having excruciating headaches.(b)(6) 2021 preop diagnosis: malfunctioning lumboperitoneal shunt, benign intracranial hypertension.Procedure(s): replacement of peritoneal end of lumbopentoneal shunt, and replacement of medtronic valve with codman valve.The patient tolerated the procedure well there were no complications.Ov (b)(6) 2021: patient presents today for a shunt adjustment s/p lps removal and replacement with codman valve on (b)(6) 2021.Patient states that she is doing great.She notes an improvement in headaches.She states that it still hurts to move her eyes, but this pain has slightly improved since the replacement with the codman valve.She still complains of occasional blurry vision and states that she "cannot focus ".At surgery she was set at 3.0, and is eager to go to a lower setting of 2.0.Patient has resumed taking lasix 40 mg twice daily.Ov (b)(6) 2021: patient is a 49 -year -old female with past medical history of pseudotumor cerebri presenting today for i month follow-up and shunt adjustment.Patient complains of worsening symptoms, increase in headaches, vertigo, nausea and fatigue.Overall, she feels unwell.Ov (b)(6) 2021: she is s/p lp shunt revision on (b)(6) 2021.She complains of abdominal pain and bleeding from incision site.Patient was going to go to (b)(6) er but we redirected her to the office.She states that her has are much better after the lp shunt revision.Denies fevers, chills, nausea/vomiting.(b)(6) 2021 procedures: 1.Removal of existing codman valve and peritoneal end of shunt 2.Implantation of medtronic strata valve and peritoneal shunt set at 1.5 3.Laparoscopic implant of peritoneal catheter 4.Confirmation of function of existing lumbar catheter.The patient tolerated the procedure well there were no complications.The patient returned to the recovery room in stable condition.(b)(6) 2021 pre-op diagnosis: disconnected lumboperitoneal shunt s/p vp shunt csf leak post-op diagnosis: 1.Same procedure(s) 1.Reconnection of disconnected lumboperiotoneal shunt 2.A new strain relief was placed on same and the tubing was replaced on the proximal end of the valve this was tied using a 2-0 silk tie but found to be very weak in terms of its ability to hold this was tested by manually pulling on it and it came off rather easily this was reported as a flaw of the medtronic valve system.The patient tolerated procedure 7 well and there were no complications.Ov (b)(6) 2021: presented to review stat ct abdomen.Patient has been complaining of sharp/stabbing abdominal pain since revision of lp shunt on (b)(6) 2021.She states that the abdominal pain is localized to below the incision site.In addition, she complains of high pressure headaches, nausea, and forgetfulness.She is still completing her post -op antibiotics (clindamycin).Ct abdomen/pelvis w/ contrast; lumboperitoneal shunt catheter with resolution of previous perpendicular orientation of catheter immediately adjacent to the reservoir.However there is a portion of catheter in the more posterolateral subcutaneous fat which appears slightly bent in orientation and may represent impending fracture.Stable subcutaneous fluid and skin thickening.New trace pelvic ascites.Ov (b)(6) 2021: at last visit, patient complained of sharp abdominal pain and worsening headaches.Ct abdomen was reviewed and the lp shunt was intact.Patient shunt was adjusted from 1.50 to 0.5.Today, patient is doing better but still complains of sharp abdominal pain around the incision site.In addition, she is having some has throughout the day when she is upright and moving around.She finds some relief with lying prone.She would like to stay at her current setting.Ov (b)(6) 2021: presenting for shunt adjustment (s/p re -exploration and connection of lp shunt (b)(6) 2021).On (b)(6) 2021, her shunt was confirmed at 0.5 and kept at that setting - per patient request.Patient has continued to have has that are worse throughout the day and better when lying down.Has are generalized and make her feel tired/fatigued.Patient saw dr.(b)(6) , neuroopthalmologist, who recommended changing shunt to 1.0 due to low pressure has.Ov (b)(6) 2021: patient is a 50 -year -old female with past medical history of benign intracranial hypertension and chiari malformation presenting today for week follow-up (s/p re -exploration and connection of lp shunt (b)(6) 2021).Patient continued to complain of sharp abdominal pain in her right and left flank region.Today, she also complains of headaches that are worse with lying down.Occasionally she experiences occipital has, she states that they occur randomly throughout the day.She believes that she is under shunting since has worsen when she bends over and lay down.She also complains of double vision, both eyes but worse in the left.Her current setting was confirmed at 1.0 at lv.Ov (b)(6) 2021: she continues to experience sharp abdominal pains, occasionally worsened after eating.The abdominal pain worsens her has.Has are described as sharp pain behind the eyes.She has had good days and bad days.Ov (b)(6) 2021: presenting today for follow-up requested by patient (s/p re -exploration and connection of lp shunt (b)(6) 2021).Patient continues to complain of sharp right flank abdominal pain.She states that the pain is unbearable.She also feels "sick to her stomach" and complains of a dull aching pain in her upper mid -section.She states that she has horrible diarrhea and feels constantly hot.Patient states that she feels like she has an 'infection".She also complains of constant headaches, regardless of position.She hasn't been as active or walking her dog as much.She has been exhausted and more depressed than normal.Patient recently saw dr.(b)(6) who believes patient could have an abscess in her abdomen.Per patient, her eye pressure is slightly decreased, as checked by dr.(b)(6).(b)(6) 2021 procedure(s): 1.Exploration of lumbarperitoneal shunt valve area 2.Removal of existing lumbarperitoneal shunt at the valve peritoneal side 3.Replacement of existing valve and abdominal tubing to a more medial location.4.Numerous cultures 5.The plan of the surgery was to explore the valve area and take cultures to remove the and existing valve and abdominal catheter and take cultures to explore abdominally the area of the ieft upper quadrant where the patient was exhibiting pain and look for any signs of intra-abdominal abscess.The final goal was to move the abdominal catheter into a different location.All of these were achieved.Ov (b)(6) 2021: presenting today for follow-up requested by patient (s/p revision of lp shunt and removal of abdominal adhesion (b)(6) 2021).Shortly after surgery, patient notes improvement in her abdominal pain.Has have decreased.Still experiencing sharp pain over incision site.However, she is no longer the pain in her diaphragm or left upper quadrant.Ov (b)(6) 2021: presenting today for lp shunt adjustment (s/p revision of lp shunt and removal of abdominal adhesion (b)(6) 2021).Patient complains of rlq abdominal pain and headaches for the past 1.5 month.Patient states that she has highs and lows.On her lows, she complains of abdominal pain, fatigue, hot/sweaty and diarrhea.She started levaquin x5d day with her pcp.Has are localized behind her head, aching pain, associated with neck pain.Ov (b)(6) 2021: presenting today for shunt adjustment post mri (sip revision of lp shunt and removal of abdominal adhesion (b)(6) 2021).Patient presented to the ed on (b)(6) 2021 s/p low back pain.She reports that she was helping lift her friend who was falling off the bed when she developed sudden back pain.Ct abdomen and mri lumbar spine were negative.Pain believed to be due to muscle sprain.There was evidence of a small 3mm non -obstructing renal stone which the ed provider did not believe was the source of her pain.- prior to this, patient states that her headaches wax and wane.Today, patient states that she "just wants the fluid dumped" because of her pressure headaches.- on a positive note, patient "feels like herself again" and isn't feeling as depressed.Ov (b)(6) 2021: presenting today for follow-up requested by patient (s/p revision of lp shunt and removal of abdominal adhesion (b)(6) 2021.Patient continues to complain of high pressure headaches that are "squeezing her head'.Also notes increased blurry vision and sharp right flank pain over shunt valve.Patient is here today because she is "convinced the valve isn't working" and wants the valve to be tapped or replaced.She feels as though she is never shunting enough and notes that the only time she felt "normal" was when she had the self-adjusting valve.- she will be seeing dr.(b)(6) , pain specialist, (b)(6) for trigger point injections for neck pain.Ov (b)(6) 2021:presenting today for follow-up (s/p removal of lp valve and peritoneal catheter and replacement with spetzler integra valveless peritoneal shunt (b)(6) 2021)- - since finishing antibiotics, patient notes that her fever has subsided.- remarks that she is "finally starting to feel like [herself]" - still complains of headaches that are daily but much improved since self-adjusting valve.No known pattern with headaches.Patient reports that with this valve, she is "shunting more" than the most open setting on the shunt would allow.- continues to have abdominal tenderness over incision.Ov (b)(6) 2022: presenting today for follow-up requested by patient.- overall, patient is doing very well since removal of medtronic valve and placement of self-adjusting shunt.Headaches improving if not gone.Energy levels have improved.Now doing pt which was never possible before with abdominal pain.Still has occasional sharp abdominal pain but significantly improved after removal of medtronic shunt valve.- reports that she was very unhappy and "miserable" when she had the medtronic valve: depressed, anxious, fatigued, lethargy, severe abdominal pain, persistent low pressure headaches.Now, she is significantly better and very happy with her quality of life.
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