BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3203353 · Received July 2, 2013

    Report

    Report Number
    3006630150-2013-01357
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. THE PATIENT¿S SHOCKING SENSATION WAS NOT DEVICE RELATED. THE PATIENT HAD A HISTORY OF BEING ELECTROCUTED (NOT DEVICE RELATED) WHICH BURNED UP THE BATTERY. THE EXPLANTED IPG 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 DEVICE 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 WAS SHOCKED AND SUBSEQUENTLY EXPERIENCED COMMUNICATION DIFFICULTY BETWEEN THE REMOTE CONTROL AND IPG. THE PATIENT¿S REMOTE CONTROL DISPLAYED AN ERROR CODE INDICATING A POTENTIAL PROBLEM WITH THE IPG. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING COMMUNICATION DIFFICULTY BETWEEN THE REMOTE CONTROL AND IPG. THE PATIENT HAD A HISTORY OF BEING SHOCKED WHICH WAS NOT DEVICE RELATED. THE PATIENT¿S IPG WAS GETTING AN ERROR CODE INDICATING A POTENTIAL PROBLEM WITH THE IPG. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS SHOCKED AND SUBSEQUENTLY EXPERIENCED COMMUNICATION DIFFICULTY BETWEEN THE REMOTE CONTROL AND IPG. THE PATIENT¿S REMOTE CONTROL DISPLAYED AN ERROR CODE INDICATING A POTENTIAL PROBLEM WITH THE IPG. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303030 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR