BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3802862 · Received May 9, 2014

    Report

    Report Number
    3006630150-2014-01015
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    June 7, 2013
    Report Date
    March 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2316-50, SERIAL/LOT #: (B)(4), DESCRIPTION: INFINION 1X16 PERC LEAD KIT-50 CM; MODEL #: SC-3400-30, SERIAL/LOT #: (B)(4), DESCRIPTION: INFINION SPLITTER 2X8 KIT (30 CM).

    Additional Manufacturer Narrative · 1

    SC-2316-50 (SN (B)(4)): DEVICE EVALUATION INDICATED MULTIPLE CABLES OF THE LEAD WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE BENT/KINKED LOCATION WAS 1 CM FROM THE SET SCREW MARK OF THE CLIK ANCHOR. THE BROKEN CABLES RESULTED IN THE REPORTED COMPLAINT OF HIGH IMPEDANCE. THE BROKEN CABLES WERE STILL CONTAINED INSIDE THE LEAD BODY. SC-2316-50 (SN (B)(4)): DEVICE EVALUATION INDICATED THAT THE LEAD PASSED ELECTRICAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE LEAD BODY WAS FRACTURED AT THE PROXIMAL END JUST BEFORE THE RETENTION SLEEVE. EVALUATION DID NOT REVEAL ANY FRACTURED CABLE AND FOUND A SET SCREW MARK DISTAL OF THE RETENTION SLEEVE. THIS INDICATED THAT THE LEAD PROXIMAL END WAS OVER-INSERTED INTO THE ASSOCIATED LEAD SPLITTER AND IT COULD HAVE RESULTED IN THE MIS-REGISTRATION OF THE LEAD CONTACTS TO THE SPLITTER CONTACTS, CAUSING HIGH IMPEDANCE READINGS. SC-3400-30 (SN (B)(4)): DEVICE EVALUATION INDICATED THAT THE LEAD SPLITTERS PASSED VISUAL, ELECTRICAL, AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. A TEST INFINION LEAD WAS INSERTED INTO THE SPLITTER CONNECTOR WITHOUT ANY ANOMALIES. DEVICES EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE LEADS WERE PRODUCING HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THE LEADS AND LEAD SPLITTERS WERE REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE LEADS WERE PRODUCING HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THE LEADS AND LEAD SPLITTERS WERE REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280346 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR