Model Number 97714 |
Device Problems
Disconnection (1171); Migration or Expulsion of Device (1395)
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Patient Problems
Weakness (2145); Complaint, Ill-Defined (2331); Coma (2417); Loss of consciousness (2418); Ambulation Difficulties (2544); Lethargy (2560); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/20/2017 |
Event Type
Injury
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Manufacturer Narrative
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Section d information references the main component of the system and other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6)2017, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6)2017, product type: lead.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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Information was received from a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) with non-malignant pain.It was reported the patient was implanted in (b)(6) and both lead tips were at t9.It was stated one of the leads disconnected from the ins and migrated to the brain.Surgery was being performed today to remove the ins.The rep stated they had been looking at scans for hours and it appeared that the lead was epidural and it crossed into the intrathecal space at t1/c7.It was noted the patient had cervical spine surgery in the past and some other surgeries.No falls or trauma were associated with this event.No symptoms or further complications were reported.
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Manufacturer Narrative
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Information references the main component of the system and other applicable components are: product id (b)(4) lot# (b)(4) implanted: (b)(4) 2017.Explanted: product type lead product id 977a260 lot# serial#(b)(6) implanted: (b)(6) 2017 explanted: product type lead h6.Patient code (b)(6) no longer applies.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 again reporting that the patient's right side lead migrated to the brain and was removed.It was reported that the patient had been feeling weak and went to the hospital on (b)(6) 2017, at which time they discovered that the lead had migrated to their brain.It was reported that the lead had been removed.It was reported that the event occurred on (b)(6) 2017.No further complications were reported/anticipated.
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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 received from the patient reported that a replacement recharger and an adhesive disc were to be sent to them to facilitate recharging.It was reported that the patient was getting physical therapy but still having other problems.The patient reported previously reported issue about the lead migration and having surgery to fix it.
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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 from the patient and the healthcare provider.The patient reported previously reported issues with the lead and asked if the stimulator was still working due to the lead issue.The healthcare provider (hcp) reported that the stimulator was working and that it just needed to be charged.No further complications were reported.
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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 from a manufacturer's representative (rep).It was reported the ins was never explanted, the only thing explanted was the lead that migrated to the brain.The cause of the disconnection remains unknown.The explanted lead was at the hospital for evaluation.No further complications were reported.
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Manufacturer Narrative
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Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.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 rep on (b)(6) 2018, reporting that they were making sure that the information about the lead migrating to the patient¿s brain was recorded.It was reviewed that there was a record of it.The rep stated that no one from the manufacturer reached out to the rep or the patient after the issue.The patient was now asking if the manufacturer could help pay for the replacement of the implant, because they currently only had the one lead, so they wanted a whole new system.Additional information was received from the patient and their husband on (b)(6) 2018, reporting that the ins was implanted on their right hip and they had two leads implanted, one going to the t1, which migrated into the spinal cord and to their head.The patient was rushed to the hospital for an emergency surgery and they removed the lead.It was reported that since then the patient had been lethargic, couldn¿t walk and had been doing physical therapy.It was reported that they were using a walker and a wheelchair.The patient reported that they were in a coma for four days and blacked out when the incident happened.They stated that the lead was removed and sent back to the manufacturer, but they hadn¿t heard back form anyone as to what happened.The two stated they hadn¿t heard back from anyone at the manufacturer.It was reported that the manufacturer representatives (reps) were all aware of the issue.It was stated that they met with the rep last week and they were also concerned and aware of their concerns.The patient/husband did not have the name of the rep.The patient stated that they wanted to know what the manufacturer would do for them because ¿they almost died and no one called them¿.The patient stated that they had called the manufacturer¿s help line, and no one called them back.They stated that they had gone through a lot of expenses and extra equipment and they wanted to get back to a normal life and wanted to how this could be done.They stated that the doctor said it would take time, a year or a year and a half.The caller asked if the patient was a case study and asked if they needed to get legal advice.They were frustrated, because no one called them.It was confirmed that the patient had their ins and left lead still implanted.Patient services checked for the lead status and stated that the lead was not returned to the manufacturer.They called the patient back and reviewed that the lead had not been sent back to the manufacturer.It was reported the event occurred on (b)(6) 2017.It was noted that the patient was going to need a replacement and another lead put in and wanted to know about assistance from the manufacturer in paying for it.No further complications were reported/anticipated.Additional information was received from the rep on (b)(6) 2018 reporting that neither the healthcare provider (hcp) or patient made them aware of the patient being in a coma or that fact that they almost died.They also mentioned that the patient had been in a wheelchair when they first met them.No further complications were reported/anticipated.
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Search Alerts/Recalls
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