BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3200457 · Received July 1, 2013

    Report

    Report Number
    3006630150-2013-01340
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-1110-02, SERIAL #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG) MODEL #: SC-2316-70, SERIAL #: (B)(4), DESCRIPTION: INFINION 70 CM LEAD KIT.

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE EVALUATION INDICATED THAT THE LEAD PASSED MECHANICAL TEST PERFORMED. HIGH IMPEDANCE READINGS WERE REGISTERED AT CONTACTS # 1, 2, 3, 4, 7, 8, 9, 10, 11, 12, 15 AND 16. THIS LOCATION APPEARS TO BE THE SITE WHERE THE SUTURES WERE POSITIONED, 1CM FROM THE CLIK ANCHOR SITE. THE BROKEN CABLES RESULTED IN THE REPORTED COMPLAINT. (B)(4): THE COMPLAINT WAS NOT VERIFIED. THE LEAD PASSED ALL TESTS INCLUDING VISUAL, IMPEDANCE, AND DIAMETER AND ELECTRODE PITCH TEST. A TEST INFINION LEAD WAS INSERTED INTO THE SPLITTER CONNECTOR WITHOUT ANY ANOMALIES. DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS. (B)(4): DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. ALL IMPEDANCE READINGS WERE WITHIN NORMAL RANGE. HIGH IMPEDANCE READINGS COULD NOT BE DUPLICATED IN THE LAB. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS. (B)(4) THE CLIK ANCHOR IS INTACT AND NO PARTS OF IT ARE MISSING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT STOPPED FEELING THE STIMULATION AND HIGH IMPEDANCE WAS NOTED WHEN PUTTING PRESSURE ON THE SPLITTER. THE PHYSICIAN BELIEVED THE SPLITTER WAS DEFECTIVE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN EVERYTHING WAS EXPLANTED AND REPLACED WITH NEW ONES. FLUID AT THE HEADER OF THE IPG WAS ALSO DISCOVERED BY THE PHYSICIAN. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT STOPPED FEELING THE STIMULATION AND HIGH IMPEDANCE WAS NOTED WHEN PUTTING PRESSURE ON THE SPLITTER. THE PHYSICIAN BELIEVED THE SPLITTER WAS DEFECTIVE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN EVERYTHING WAS EXPLANTED AND REPLACED WITH NEW ONES. FLUID AT THE HEADER OF THE IPG WAS ALSO DISCOVERED BY THE PHYSICIAN. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT STOPPED FEELING THE STIMULATION AND HIGH IMPEDANCE WAS NOTED WHEN PUTTING PRESSURE ON THE SPLITTER. THE PHYSICIAN BELIEVED THE SPLITTER WAS DEFECTIVE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN EVERYTHING WAS EXPLANTED AND REPLACED WITH NEW ONES. FLUID AT THE HEADER OF THE IPG WAS ALSO DISCOVERED BY THE PHYSICIAN. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299229 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-3400-30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR