Model Number 3286 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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The investigation results will be provided on the final report.
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Event Description
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Related manufacturer report number 1627487-2019-08867.Related manufacturer report number 1627487-2019-08869.It was reported that post implant procedure, impedance issue was observed on several contacts.Patient had reflex sympathetic dystrophy.A revision procedure occurred on (b)(6) 2019 to revise the leads upon which during the procedure the leads were stuck to the implantable pulse generator.The screw of the lead was difficult to remove.Physician used a new screw however it was unsuccessful.Device therapy was turned off.Patient was being treated with medicine to help resolve the pain.No further information is available at this time.
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Event Description
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Related manufacturer report number 1627487-2019-08867.Related manufacturer report number 1627487-2019-08869.New information received states that both leads remains implanted and the issue has not been resolved.No further information is available at this time.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Related manufacturer report number 1627487-2019-08869.
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Event Description
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Related manufacturer report number 1627487-2019-08867.Related manufacturer report number 1627487-2019-08869.New information received states that the device was explanted on (b)(6) 2019.There were no complications during the procedure.
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Search Alerts/Recalls
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