ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD
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Model Number 3186 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Event Description
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It was reported that during a procedure on (b)(6) 2020 (reference mdr-2020-37945) the physician was unable to explant the fractured lead completely, as the end of the lead was in the muscle belly.As a result, remaining portion of the lead was left in place.
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Search Alerts/Recalls
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