BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3073264 · Received April 23, 2013

    Report

    Report Number
    3006630150-2013-00839
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    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 SOURCE OF THE COMPLAINT COULD NOT BE DETERMINED AS THE DEVICES HAD BEEN DAMAGED DURING THE EXPLANT PROCEDURE. DEVICE EVALUATION INDICATED THAT THE IPG CASE WAS PUNCTURED. THE DEVICE CHARACTERISTICS HAVE BEEN CHANGED. THE DEVICE COULD NOT ESTABLISH COMMUNICATION WITH THE REMOTE CONTROL DUE TO THE ERROR CONDITION. DEVICE EVALUATION INDICATED THAT THE PADDLE LEAD WAS CUT INTO PIECES. DAMAGE TO THE LEAD IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-1110, SERIAL/LOT #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION WHEN THE STIMULATION WAS ON AND THAT IT WOULD TAKE A LONG TIME TO CHARGE THE IPG. IT WAS ALSO NOTED THAT SEVERAL CONTACTS OF THE LEAD WERE NOT FUNCTIONING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION WHEN THE STIMULATION WAS ON AND THAT IT WOULD TAKE A LONG TIME TO CHARGE THE IPG. IT WAS ALSO NOTED THAT SEVERAL CONTACTS OF THE LEAD WERE NOT FUNCTIONING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175233 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR