BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3831646 · Received May 26, 2014

    Report

    Report Number
    3006630150-2014-01189
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEAD WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S SCS SYSTEM STOPPED WORKING. HIGH IMPEDANCE WAS NOTED. THE PATIENT UNDERWENT A REVISION WHEREIN THE LEAD WAS REPLACED AND THE PHYSICIAN OBSERVED THAT THERE WAS SOME FRAYING AT THE BASE OF THE LEAD. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S SCS SYSTEM STOPPED WORKING. HIGH IMPEDANCE WAS NOTED. THE PATIENT UNDERWENT A REVISION WHEREIN THE LEAD WAS REPLACED AND THE PHYSICIAN OBSERVED THAT THERE WAS SOME FRAYING AT THE BASE OF THE LEAD. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309898 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR