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| Model Number 8637-20 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erosion (1750); Cellulitis (1768); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Sepsis (2067); Pressure Sores (2326); Injury (2348); Weight Changes (2607); Tissue Breakdown (2681)
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| Event Date 01/09/2018 |
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Event Type
Injury
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Manufacturer Narrative
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Product id: 8703, lot# j94142195, product type: catheter.Other relevant device(s) are: product id: 8703, serial/lot #: j94142195, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was provided by a healthcare provider via a manufacturer¿s representative (rep) regarding an implantable intrathecal pump.The indication for use was intractable spasticity and movement disorders.It was reported that the patient¿s pump was explanted.The reason for the explant was an infection.It was unknown when the patient first started experiencing the infection that led to the explant.It was unknown what symptoms the patient experienced related to the explant.It was unknown if any additional actions/interventions were taken to resolve the infection.That led to the explant.The patient¿s weight at the time of the event was unknown.It was indicated that the pump would not be returned, and that the rep learned of the explant after the device was explanted.No further complications were reported or anticipated.Additional information was received from a healthcare provider (hcp) on (b)(6) 2018.The pump was used to deliver an unknown type of baclofen [2000 mcg/ml] at 399.9 mcg/day and preservative-free morphine sulfate [6.3 mg/ml] at 1.2596 mg/day.The hcp provided progress notes for the patient.It was noted that at the pump refill appointment on (b)(6) 2017, the patient was stable with her pain and had no new complaints.The patient tolerated the refill procedure well.The patient's next refill was due on or before (b)(6) 2018.At the following refill appointment on (b)(6) 2018, it was reported that the patient was stable from the standpoint of her pain and spasticity, but she had a new wound on her back and was seeing a wound care center.Upon examination, the pump implant site was intact in the left lower quadrant.The refill procedure was performed using aseptic technique.The implant site was prepped with betadyn (or hibiclens + isopropyl alcohol).The usual sterile draping was performed.The reservoir port was entered with a 22g huber needle and 3 ml of clear aspirate was obtained.20 ml of intrathecal medication was instilled.The patient tolerated the procedure well.It was noted that eri (elective replacement indicator) was 5 months at the time of the (b)(6) 2018 refill, and the patient and the hcp mutually agreed to proceed with replacement of the pump in (b)(6) 2018.It was stated that the plan was to proceed with pump replacement and possible catheter revision in april.It was noted that the patient was aware of the procedure and risks, including infection, bleeding, increased pain, and pump failure, as well as the possible need to replace/revise the catheter.It was noted that the patient would need assistance at home for the first 3-4 days post-operative and would wash with hibiclens pre-operatively.The patient's vital signs on (b)(6) 2018 were reported as: heart rate was 83 beats/minute, blood pressure was 154/86 mm hg, and weight was 110 pounds.It was reported that the patient called the hcp's office on (b)(6) 2018 and reported that she has a wound on the left side of buttocks (open wound).It was stated that a nurse came to the patient's home 6 days to clean and redress her wound.They had not set a date for closing the wound.The patient's managing hcp's office called the nurse and asked if they can send their last office note about the size of the wound.An addendum was added to the patient's (b)(6) 2018 appointment record on (b)(6) 2018.It was reported that they received information from home care that stated that the patient had a large open wound on the left side of her buttock.It was indicated that since a pump replacement was scheduled for (b)(6) 2018 due to end of life with an eri of 5 months at her last refill in (b)(6) 2018.Per the addendum, home care was going to notify the patient and let her know that they would need to taper her baclofen down and begin oralbaclofen to minimize the risk of abrupt intrathecal baclofen discontinuation in the event that the pump stops completely before they need to replace it.The patient had an appointment on (b)(6) 2018 for a pump adjustment.It was stated that the patient was stable at the time of the visit; however, she had a large pressure ulcer/wound over the lower thoracic spine which she stated was very deep.The patient was being treated via a wound care center and was not on any antibiotics.Per the patient, she had been told that there was no infection at that point.It was noted that they were tentatively scheduled to replace the intrathecal baclofen pump in early april 2018 due to near end of life.However, in light of the large pressure ulcer, it was indicated that they may have to postpone the replacement due to risk of infection.The patient stated that she had been told that there is currently no evidence of infection in the wound, which was being treated at a medical center and that she was not on any antibiotics.At the time of the appointment, they were going to begin titrating the intrathecal baclofen (itb) down to minimize the risk of itb withdrawal.They were going to contact the patient's wound care physician and discuss this with her.Per the managing hcp, if they would put off the pump replacement, they would continue with their plan for downward titration of the itb.Otherwise they would proceed with replacement as scheduled in april, as there was no infection and there was evidence of consistent healing.The patient's vital signs on (b)(6) 2018 were reported as: heart rate was 85 beats/minute, blood pressure was 135/74 mm hg, and weight was 110 pounds.The patient had an appointment on (b)(6) 2018 for a pump adjustment.Regarding the history of present illness, the managing hcp spoke with the rn (registered nurse) at the wound care center.At the time of the visit, there was no evidence of infection with the open wound of the lower lumbar spine.The hcp expressed his concern regarding the intrathecal catheter where it is tunneled around the flank.During the examination, the dressing over the lower lumbar spine was removed.It was reported that there was a large ulcer down to the spinous process.There was no drainage or mal-odor.It was reported that the hcp personally reviewed a lumbar spine x-ray from (b)(6) 2018, demonstrating the intrathecal catheter on the left side and it appeared that the catheter tip was at the t11/t!2 interspace and entering the spine from the left l2/3 interspace.The hcp informed the patient of the risk of meningitis given the open wound and indicated that this would preclude itb pump replacement.It was stated that the plan was to continue to slowly titrate the itb down, and possibly begin oral baclofen should the spasticity become an issue.It was indicated that if not, they may be able to explant the catheter and pump.On 2018-mar-15, they decrease the itb an additional 23%.It was noted that eri was 3 months.The patient returned for an appointment on (b)(6) 2018 for a pump adjustment.It was reported that the patient was stable with her pain.It was stated that the patient was continuing to care for her large lower lumbar wound, and she has a small new wound on the right buttocks region.It was noted that as they slowly titrated the itb, there had been any significant change in her spasticity.It was indicated that they would continue to titrate the itb down, and they made an additional 30% reduction today.It was stated that they would fill the pump and continue with the dose reduction due to the inability to proceed with a pump replacement due to the large open wound.It was noted that if the wound progresses, they may need to explant the catheter and pump.The patient's vital signs on (b)(6) 2018 were reported as: heart rate was 90 beats/minute, blood pressure was 77/47 mm hg, and weight was 100 pounds.It was reported that on (b)(6) 2018, the patient contacted the hcp's office and reported that she was in the hospital.It was noted that the wound care pa (physician's assistant) also called the wound care physician.It was reported that the catheter was exposed in the wound.It was stated that the patient missed an appointment with the wound care pa.It was reported that the patient now had cellulitis on the left upper back and was admitted to the hospital with sepsis.It was noted that the pa (neurosurgery) was down at ct scan.It was thought they may have to remove the pump.It was reported that on (b)(6) 2018, the patient called to inform the hcp's office that the pump was scheduled to be removed at 8 a.M.On (b)(6) 2018 and that she had an infection.On (b)(6) 2018, it was noted that the patient was put on morphine 60 mg, twice a day.No further complications were reported.The patient¿s medical history included paraparesis of both lower limbs, colostomy, spastic paraplegia, spinal cord injury, and chronic pain syndrome.Allergies included phenergan, sulfa, and demerol.No surgical history was documented.Family history was non-contributory.There was no history of hospitalization.The patient was a non-smoker.The patient¿s concomitant medications included xanax 0.25 mg tablet (orally daily), aleve 220 mg tablet (1 tablet as needed orally), lisinopril 10 mg tablet (1 tablet orally once a day).
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Manufacturer Narrative
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Product id (b)(4) lot# j94142195 implanted: (b)(6)1994 explanted: (b)(4)2018 product type catheter.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Clarification regarding the appointment on (b)(6)2018.It was noted that as they had slowly titrated the intrathecal baclofen down, there had not been any significant change in the patient's spasticity.
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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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Event Description
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Additional information was received via saol therapeutics.It was noted that as per a spontaneous report from a healthcare provider, the patient¿s weight was indicated as being 51.25 kg.It was further noted that the patient had a weight of 113 lbs on (b)(6) 2017, was 110 lbs on (b)(6) 2018 and (b)(6) 2018, and was 100 lbs on (b)(6) 2018.The patient¿s weight decreased.It was noted the patient's pump and catheter were explanted to prevent the likelihood of central nervous system infection.It was further indicated that based on the information provided, the event was likely not related to baclofen therapy and likely decubitus in nature, although the etiology was not provided.
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Manufacturer Narrative
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Concomitant medical products: product id: 8703, lot#: j94142195, implanted: (b)(6) 1994, explanted: (b)(6) 2018, product type: catheter.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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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