Model Number 37601 |
Device Problems
Device Operates Differently Than Expected (2913); Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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See report # 3004209178-2018-14186 for other implantable neurostimulator involved in this event.Analysis results for the returned implantable neurostimulator were not available at the time of this report.A follow-up report will be sent when analysis is complete.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 healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the lead was damaged during the extraction procedure on (b)(6) 2018.No environmental/external/patient factor were thought to have led or contributed to the issue.It was reported testing on the lead was done with a testing cable.All contacts showed open circuits.The physician made multiple attempts to resolve the issue by disconnecting/reconnection and testing with the clinician programmer.The physician requested a new extension and battery to try to restore therapy for the patient.The issue was resolved at the time of the report.The patient was alive without injury at the time of the report.No further complications were reported or anticipated.Additional information was received from the manufacturer representative.It was reported the patient requested another battery be opened.It was opened, not used, and returned to the manufacturer where analysis will be performed.It was reported the ins was removed because they were questioning the functionality of battery.The physician requested the battery be tested for functionality due to high impedances.The patient recovered without sequela.Additional information was received from the health care professional (hcp) via the manufacturer representative.It was clarified the explant procedure occurred on (b)(6) 2018 and the re-implant of the extensions and ins was done on (b)(6) 2018.It was reported after dissecting the lead and reconnecting the lead to the extension connection, there were open circuits.The distal end of the lead seemed to be frayed per the physician which was believed to be the cause of the open circuits.
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Manufacturer Narrative
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Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.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 a manufacturer representative (rep).It was clarified the hcp requested to switch out the extension first thinking it could have been a faulty extension.Then they requested to try another battery.The damage to the lead occurred while dissecting the leads and removing the boot and disconnection the lead/extension connection during the reimplant.
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Manufacturer Narrative
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Analysis results of the implantable neurostimulator (serial # (b)(4)) and the extension (serial# (b)(4)) revealed no anomalies.Good impedance was observed.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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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 indicating they were having difficulty getting therapy turned back on and the hcp thought it might be a broken lead.It was noted that the rep did a "programming trick" and was able to get it working.It was noted that the last 3-4 months they have been having trouble again with the right stm lead.An oor occurs when they program the right stn lead, this has been an ongoing issue since implant.Impedances were out of range on 0, 1, 8, 10 at greater than 2000 ohms.
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Search Alerts/Recalls
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