BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2770476 · Received October 3, 2012

    Report

    Report Number
    3006630150-2012-01782
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S IPG WAS REPLACED. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS THEY WERE 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 A PATIENT WILL UNDERGO A REVISION DUE TO THEIR IPG NO LONGER HOLDING A CHARGE. THE PATIENT HAD AN ABDOMINAL BIOPSY AND CT SCAN AND THE PHYSICIAN SAYS IT IS POSSIBLE THAT ELECTROCAUTERY WAS USED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WILL UNDERGO A REVISION DUE TO THEIR IPG NO LONGER HOLDING A CHARGE. THE PATIENT HAD AN ABDOMINAL BIOPSY AND CT SCAN AND THE PHYSICIAN SAYS IT IS POSSIBLE THAT ELECTROCAUTERY WAS USED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WILL UNDERGO A REVISION DUE TO THEIR IPG NO LONGER HOLDING A CHARGE. THE PATIENT HAD AN ABDOMINAL BIOPSY AND CT SCAN AND THE PHYSICIAN SAYS IT IS POSSIBLE THAT ELECTROCAUTERY WAS USED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR