ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD
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Model Number 3186 |
Device Problems
High impedance (1291); Migration (4003)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event and therapy date are estimated.During processing of this complaint, attempts were made to obtain patient weight.
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Event Description
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Related manufacturer reference number: 3006705815-2021-04281.It was reported that one of the patient's leads migrated, high impedances were measured at the lead contacts, and the patient lost effective therapy.As a result, surgery occurred in which the lead was explanted and replaced, which resolved the issue.It is not known which of the leads had the issue, so both applicable leads are being reported.
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Manufacturer Narrative
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A patient experienced lead migration was reported to abbott.It was determined that one of the patient's leads migrated, had high impedances, and the patient lost effective therapy.As a result, the patient's the lead was explanted and replaced, which resolved the issue.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 event could not be conclusively determined.
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Search Alerts/Recalls
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