Model Number 37714 |
Device Problems
Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
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Patient Problems
Injury (2348); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Other applicable components are: product id: 37761, serial#: (b)(4), product type: recharger.
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Event Description
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Information was received via a manufacturer representative from a patient who was implanted with a neurostimulator for post lumbar laminectomy syndrome and spinal pain.It was reported that this event occurred post-operation.It was reported that the patient hadn¿t charged since around (b)(6) 2016 and now could not connect with the implantable neurostimulator recharger or patient programmer.The patient had surgery in (b)(6) 2016 and hadn¿t resumed recharging since then.No actions or interventions had been taken to resolve the overdischarge, but an appointment for a physician mode recharge was to be determined at the time of the report.The issue was not resolved at the time of the report.No surgical interventions were planned or performed at this time.There were no patient symptoms reported.Additional information was received from a manufacturer representative on (b)(6) 2017 reporting that an overdischarge was alleged.The last charge session was (b)(6) 2016 due to non-compliance and an issue with recharging.There was difficulty recharging.In (b)(6) a new product (implantable neurostimulator recharger (insr) ) was sent out but the patient did not have success and gave up.The patient had an unrelated surgery and had put off troubleshooting with the insr until now.It was reported that a manufacturer representative had previously reported.The caller reported that the patient agreed that they were not a good candidate for the rechargeable device.The caller was questioning if the patient had memory issues.The caller noted that in the notes from the post-operative meeting in (b)(6) 2013 the patient had good coupling with 8 bars.The caller reported that the patient no longer wanted another connector pin and wanted the ins replaced with a primary cell battery.The manufacturer representative reported that the patient¿s desktop charger has a bent connector pin.No symptom was reported.The caller had already talked to repair regarding the desktop charger.It was noted by the manufacturer that the desktop charger was not replaced.
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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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Correction as the event is a product problem and an adverse event.If information is provided in the future, a supplemental report will be issued.
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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 consumer.It was reported no steps were taken due to an injury from auto-pedestrian accident.The patient was planning to deal with it soon.No further complications were reported.
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Search Alerts/Recalls
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