Model Number 3186 |
Device Problems
Disconnection (1171); High impedance (1291); Migration (4003)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 07/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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¿date of event¿ is estimated.The results/ method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturer reference number: 3006705815-2020-31026.It was reported that the patient fell and experienced ineffective therapy.Diagnostic testing revealed high impedance on multiple contacts of one lead.Imaging showed that the lead migrated.Surgery may occur to address the issue.It is unknown which lead is related to the issue so all suspected leads are being reported.
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Event Description
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Additional information was received that the right-side lead had slightly migrated and the left-side lead had slightly come out of the ipg header.Surgery occurred on (b)(6) 2020 during which the left-side lead was reinserted into the ipg header to address the issue.It is unknown which lead is the right-side lead and which lead is the left-side lead.
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Manufacturer Narrative
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Corrections: b5: the previous report should have included the following information: related manufacturer reference number: 1627487-2020-32047 d11: the previous report should have included the following information: medical product: scs ipg therapy date: (b)(6) 2020.
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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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