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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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| Model Number 97800 |
| Device Problems
Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)
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| Patient Problems
Hemorrhage/Bleeding (1888); Incontinence (1928); Itching Sensation (1943); Undesired Nerve Stimulation (1980); Pain (1994); Burning Sensation (2146); Discomfort (2330); Electric Shock (2554); Weight Changes (2607); Insufficient Information (4580)
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| Event Date 10/26/2023 |
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Event Type
malfunction
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Event Description
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Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that patient stated with the trial everything was great and they went from not being able to control their bladder at all to 85% improvement at least.Pt stated they were explained to that the permanent implant is a little bit different than the trial.Pt stated they must have got education under anesthesia after implant but reported they are not feeling stimulation sensation down in their pelvic area/vaginal area like they did before.Pt reported the only place where they really feel any stimulation is where they had their "stitches put" and if they increase stimulation they don't feel anything in pelvic area and reported they "feel it on there and it feels like a radiation like burning sensation".Pt clarified they are feeling this sensation at the place where they got the most stitches so they would assume that would be where the implant is.Pt confirmed feeling th is in their right upper gluteal area at the spot where they place communicator when increasing stimulation.Pt reported it feels like burning pain there.Reviewed therapy/stimulation overview and expectations.Pt also reported when they try to raise arrows up and down they have to "mash and mash" so pt inquired if that is the problem.Reviewed general use of external devices and therapy overview.Pt clarified they have to really forcefully tap on the screen in order to increase stim and sometimes they have to keep doing it and after a while it will "go up by itself almost".Agent inquired if pt is holding down arrow and pt stated they are tapping it and have also tried holding arrow and stated they have tried several things.Pt also reported a while ago they were sitting in their electrical lift chair and they felt "like a shock" where they have the stitches.Pt inquired if lift chair is considered emi.Reviewed role of patient services and redirected pt to managing healthcare provider to further address.Reviewed emi compatibility and redirected pt to hcp to discuss compatibility with electrical lift chair.Recommended pt discontinue use as able until pt follows up with hcp.Pt reported their implant site feels sore and they don't know if pain is from stimulator so pt stated they don't know if th ey should just turn off their implant because they are "peeing like crazy" and it's not making any difference anyway.Reviewed consideration to turn off implant until pt follows up with hcp.Agent reviewed general use of handset and communicator and walked pt through how to connect with their implant to turn off implant.Pt confirmed turned off implant.Agent asked for event date for when pt noticed all issues first started and pt stated after they had the surgery and when pt had to pee and they got home they made it all the way to the bathroom but reported that night "nothing else happened" but they were having the burning sensation then.Pt inquired about what to do for mri.Reviewed general overview of mri mode.Pt also inquired if they can take a shower.Reviewed role of patient services/redirected pt to their managing hcp to discuss post op guidance and showering.Pt reported they are having some bleeding but they don't know if it's because they had hemorrhoids already.Pt reported they were still feeling a shock at their implant site when they were sitting in the lift chair and leaned back even though their implant was turned off.Patient has appointment with their dr on wednesday.Patient was redirected to their healthcare provider to address all issues reported above.
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Manufacturer Narrative
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B3: date is estimated; month and year are valid.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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Additional information was received from the patient.Patient called back and repeated previously noted information.Patient stated they saw hcp regarding issues previously noted and now patient wanted to turn ins back on.Reviewed with patient how to turn therapy back on and patient adjusted stimulation to a comfortable level.Patient will maintain stimulation and monitor symptoms.
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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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Additional information was received from the patient.Patient called back and repeated previously reported concerns.Patient said that did see the rep in november, however, then became very sick in november, was hospitalized, then had e coli, said had a very bad staph infection in their leg and also had the flu.Patient said that during this time stimulation was off and didn't make any adjustment during this time.Patient said that they just turned it back on yesterday night however hasn't noticed any improvement, has only been dry trip once to the bathroom since yesterday night.Patient said has cone thorough six pullups and if it's not leakage, it just comes whenever they stand up.Patient said that reviewed how to use the external devices on youtube however had some questions about programs.Reviewed general programming guidance and therapy information with patient.Patient to monitor and track both adjustments and symptoms.Patient also mentioned that since received implant has lost about 70 lbs, and said that the neurostimulator moves around and pinches but not very often, however, said that it was very uncomfortable until stitches healed.Patient said that it took a long time for their stitches to heal.Patient also mentioned that it really itches while was healing.Redirected patient to report and consult with managing physician.Patient also asked about use of tens and his one one bone, has two torn rotator cuffs.Other medical history included that patient has had blood clots about 10 years ago and when had bronchitis and was in bed for a month and has edema and has had sepsis before.
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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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