BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3873515 · Received June 14, 2014

    Report

    Report Number
    3006630150-2014-01345
    Event Type
    Injury
    Date Received
    June 14, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SC-1110-02 (SN: (B)(4) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE ROOT CAUSE OF THE PATIENT'S SKIN BURN COULD NOT BE DETERMINED. THE HIGHEST CHARGING TEMPERATURE AT THE PATIENT'S POCKET SITE WAS WITHIN THE LIMIT. SC-5312 (SN: (B)(4)) DEVICE EVALUATION INDICATED THAT THE CHARGER PASSED VISUAL AND PERFORMANCE TESTS PERFORMED. THREE CHARGING TESTS CONDUCTED CONFIRMED THAT BOTH IPG AND CHARGER WERE BEHAVING NORMALLY. SC-2218-70 (SN: (B)(4)) DEVICE EVALUATION INDICATED THAT THE LEAD PASSED PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE LEAD BODY WAS CUT. X-RAY INSPECTION FOUND NO OTHER ANOMALIES. DAMAGE TO THE DEVICE WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND WAS NOT CONSIDERED A FAILURE. SC-2218-70 (SN: (B)(4)) DEVICE EVALUATION INDICATED THAT THE LEAD BODY WAS CUT. DAMAGE TO THE DEVICE WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND WAS NOT CONSIDERED A FAILURE. X-RAY INSPECTIONS FOUND TWO CABLES FRACTURED AT THE CLIK ANCHOR SITE, 1 CM FROM THE SET SCREW MARK. REVIEW OF THE STERILIZATION RECORDS OF THE EXPLANTED DEVICES REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-5312 SERIAL/LOT #: (B)(4), DESCRIPTION: SCS CHARGER 2.0 MODEL #: SC-2218-70 SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S SKIN WAS BURNT WHEN CHARGING. THE POCKET SITE WAS WARM, RED, INFLAMED AND STARTING TO ATROPHY. THE POCKET SITE NEVER HEALED AND THE IPG WAS BEGINNING TO ERODE THROUGH THE SKIN. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S SKIN WAS BURNT WHEN CHARGING. THE POCKET SITE WAS WARM, RED, INFLAMED AND STARTING TO ATROPHY. THE POCKET SITE NEVER HEALED AND THE IPG WAS BEGINNING TO ERODE THROUGH THE SKIN. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351848 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention