BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2800449 · Received October 22, 2012

    Report

    Report Number
    3006630150-2012-01937
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    August 31, 2012
    Report Date
    August 31, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS KEPT 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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS VERIFIED AS THE DEVICE EXHIBITED THE SYMPTOMS OF ANALOG IC DAMAGE DUE TO HIGH-VOLTAGE TRANSIENT. IT WAS VERIFIED THAT THE PATIENT UNDERWENT CARDIOVERSION, WHICH WAS THE ROOT CAUSE OF THE DEVICE DAMAGE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS UNABLE TO TURN THE IPG ON AFTER A CARDIOVERSION WHICH WAS NON DEVICE RELATED. THE PATIENT UNDERWENT AN IPG REPLACEMENT AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS UNABLE TO TURN THE IPG ON AFTER A CARDIOVERSION WHICH WAS NON DEVICE RELATED. THE PATIENT UNDERWENT AN IPG REPLACEMENT AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR