BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2845290 · Received November 26, 2012

    Report

    Report Number
    3006630150-2012-02150
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-1110-02 SERIAL / LOT #: (B)(4) DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG) ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION WHEREIN THE PADDLE LEAD WAS REPLACED DUE TO SUSPECTED MALFUNCTION AND THE IPG WAS REPLACED PER PHYSICIAN'S PREFERENCE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. SC-8120-70 / SERIAL # (B)(4) THE COMPLAINT OF HIGH IMPEDANCES WAS VERIFIED. ALL ELECTRO WIRES OF THE PADDLE LEAD WERE FRAGMENTED AT THE SUTURE SITES. THIS EVENT WOULD CAUSE STIMULATION INTERMITTENT, LOSS AND HIGH IMPEDANCE READINGS. SC-1110-02 / SERIAL # (B)(4) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, OPERATIONAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE IPG WAS VERIFIED TO BE WORKING AS EXPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A LEAD REVISION PROCEDURE BECAUSE 14 OUT OF THE 16 CONTACTS ARE HIGHLY IMPEDED. THE PHYSICIAN WILL REPLACE THE PADDLE LEAD WITH A NEW ONE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A LEAD REVISION PROCEDURE BECAUSE 14 OUT OF THE 16 CONTACTS ARE HIGHLY IMPEDED. THE PHYSICIAN WILL REPLACE THE PADDLE LEAD WITH A NEW ONE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A LEAD REVISION PROCEDURE BECAUSE 14 OUT OF THE 16 CONTACTS ARE HIGHLY IMPEDED. THE PHYSICIAN WILL REPLACE THE PADDLE LEAD WITH A NEW ONE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A LEAD REVISION PROCEDURE BECAUSE 14 OUT OF THE 16 CONTACTS ARE HIGHLY IMPEDED. THE PHYSICIAN WILL REPLACE THE PADDLE LEAD WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR