Model Number 37602 |
Device Problems
Break (1069); Peeled/Delaminated (1454); Device Or Device Fragments Location Unknown (2590)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/06/2016 |
Event Type
Injury
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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: 3387-40, lot# l85504, implanted: (b)(6) 2000, product type: lead.
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Event Description
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Information was received from a healthcare provider (hcp) via manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator.It was reported that an exploratory procedure resulted in damage to the lead; the lead insulation pulled away from the lead wire.No diagnostics or troubleshooting was performed, they could not confirm the damage visually, and the issue was not resolved at the time of the report.It was unknown if surgical intervention was planned.It was noted the patient had a history of parkinson's disease.No patient symptoms reported.
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Manufacturer Narrative
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Device code was removed.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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A manufacturing representative reported a healthcare professional was doing a lead revision on the patient.No symptoms were reported.Patient's indication for use is movement disorders.
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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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Search Alerts/Recalls
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