Model Number 3189 |
Device Problems
Fracture (1260); High impedance (1291)
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Patient Problems
Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/30/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event and therapy date are estimated.
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Event Description
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Related manufacturer reference number: 1627487-2021-16451.It was reported that during an ipg replacement surgical procedure that occurred on (b)(6) 2021 (documented in manufacturer report 1627487-2021-16446), high impedances were measured on each electrode of one of the patient's leads.As a result, surgery may occur to address the issue.It is unknown which lead had the high impedances, so both applicable leads are being reported.
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Event Description
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Additional information was received that surgery occurred during which the lead was explanted and replaced, which which resolved the issue.A lead fracture was confirmed after the lead was explanted.
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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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Search Alerts/Recalls
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