BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3071854 · Received April 22, 2013

    Report

    Report Number
    3006630150-2013-00767
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PADDLE LEAD WAS NOT EXPLANTED, AND IT IS STILL IN PLACE IN THE PATIENT'S BODY. IN ADDITION, THE RESULT OF THE CULTURE WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS. ORAL ANTIBIOTIC, KEFLEX, WAS GIVEN TO THE PATIENT. THE PATIENT IS NOW DOING WELL.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED ELECTRICAL, AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE SOURCE OF THE COMPLAINT REGARDING THE POCKET PAIN WAS NOT VERIFIED. A REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT. CURRENT LEAKAGE TESTS AND RESIDUAL GAS ANALYSIS VERIFIED THAT THERE IS NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE AS A RESULT OF FAULTY INSULATION. HOWEVER, THE DEVICE EXHIBITED BURN MARKS ON THE CASE AND FAILED ATE TEST. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE EXPLANT PROCEDURE. MONOPOLAR ELECTROCAUTERY PROCEDURES ARE A KNOWN SOURCE OF HIGH-VOLTAGE TRANSIENT SIGNAL THAT CAN DAMAGE THE ANALOG INTEGRATED CIRCUIT (AIC-U1), (B)(4). THE ASSOCIATED LEADS WERE CUT, AND PROXIMAL END PORTIONS WERE RETURNED. THE DAMAGE TO THE DEVICES IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. REVIEWS OF THE DEVICE STERILE RECORDS FOUND NO ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT.

    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-3138-35, SERIAL #: (B)(4), DESCRIPTION: SCS PHIII EXT 35CM; MODEL #: SC-8216-50, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT'S IPG AND EXTENSIONS WERE EXPLANTED DUE TO INFECTION. SYMPTOMS WERE PAIN AND DRAINAGE AT THE LEAD INCISION SITE. THE PHYSICIAN BELIEVES THE INFECTION IS PROCEDURE RELATED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT'S IPG AND EXTENSIONS WERE EXPLANTED DUE TO INFECTION. SYMPTOMS WERE PAIN AND DRAINAGE AT THE LEAD INCISION SITE. THE PHYSICIAN BELIEVES THE INFECTION IS PROCEDURE RELATED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT'S IPG AND EXTENSIONS WERE EXPLANTED DUE TO INFECTION. SYMPTOMS WERE PAIN AND DRAINAGE AT THE LEAD INCISION SITE. THE PHYSICIAN BELIEVES THE INFECTION IS PROCEDURE RELATED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171632 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-3138-35 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention