BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3133162 · Received May 29, 2013

    Report

    Report Number
    3006630150-2013-01084
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-1110-02, SERIAL/LOT #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG). MODEL #: SC-4316, SERIAL/LOT #: (B)(4), DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.

    Additional Manufacturer Narrative · 1

    MODEL # SC-8216-50, SN (B)(4): DEVICE EVALUATION INDICATED THAT THE PADDLE LEAD WAS FOUND BROKEN CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE COMPLAINT HAS BEEN CONFIRMED. HIGH IMPEDANCE READINGS WERE REGISTERED AT CONTACTS # 5, 6,10,11,12,13,14,15 AND 16. THIS LOCATION APPEARED TO BE THE SITE WHERE THE SUTURES WERE POSITIONED FROM THE PROXIMAL END SITE. THE BROKEN CABLES RESULTED IN THE REPORTED COMPLAINT OF HIGH IMPEDANCE EXHIBITED. MODEL # SC-1110-02, SN (B)(6): DEVICE EVALUATION INDICATED THAT THE IPG EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE COMPLAINT OF HIGH IMPEDANCE WAS NOT CONFIRMED AS VARIOUS TEST LEADS WERE INSERTED IN BOTH PORTS. ALL IMPEDANCE READINGS WERE WITHIN NORMAL RANGE. MODEL #SC-4316- DEVICE EVALUATION INDICATED THAT THE CLIK ANCHOR REVEALED A MISSING PIECE OF SILICON FROM THE AREA SURROUNDING THE EYELET. THE OTHER CLIK ANCHOR EXHIBITED NORMAL CHARACTERISTICS. THIS WAS A RESULT OF THE EXPLANT PROCEDURE AND WAS NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING STIMULATION. DATABASE ANALYSIS REVEALED HIGH IMPEDANCES ON SOME CONTACTS OF THE PADDLE LEAD. THE PATIENT UNDERWENT A REVISION, DURING WHICH, THE PHYSICIAN ELECTED TO REPLACE THE PADDLE LEAD AND THE IPG.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING STIMULATION. DATABASE ANALYSIS REVEALED HIGH IMPEDANCES ON SOME CONTACTS OF THE PADDLE LEAD. THE PATIENT UNDERWENT A REVISION, DURING WHICH, THE PHYSICIAN ELECTED TO REPLACE THE PADDLE LEAD AND THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234666 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR