BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3031665 · Received April 2, 2013

    Report

    Report Number
    3006630150-2013-00600
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT REGARDING THE STIMULATION TERMINATION WAS NOT VERIFIED. THE STIMULATION OUTPUTS WERE MONITORED ON A SCOPE FOR TWO HOURS. THE OUTPUTS WERE CONSISTENT AND AMPLITUDE/PULSE WIDTHS WERE VERIFIED TO BE CORRECT ON ALL ELECTRODES. THROUGHOUT THE ENTIRE FAILURE ANALYSIS, THE UNSPECIFIED ERROR CODE WAS NOT OBSERVED. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS NOT HOLDING ITS CHARGE AFTER A NON-DEVICE RELATED MRI WAS DONE. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION DUE TO THE MRI. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS NOT HOLDING ITS CHARGE AFTER A NON-DEVICE RELATED MRI WAS DONE. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION DUE TO THE MRI. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS NOT HOLDING ITS CHARGE AFTER A NON-DEVICE RELATED MRI WAS DONE. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION DUE TO THE MRI. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134976 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR