BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3214004 · Received July 9, 2013

    Report

    Report Number
    3006630150-2013-01444
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG (SN (B)(4)) PASSED THE VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE REPORTED COMPLAINT OF THE ACID BURNS IN THE PATIENT¿S POCKET SITE COULD BE CAUSED BY THE IPG WAS NOT DUPLICATED OR CONFIRMED. CURRENT LEAKAGE TESTS AND RESIDUAL GAS ANALYSIS VERIFIED THAT THERE WAS NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE AS A RESULT OF FAULTY INSULATION. REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS. DEVICE EVALUATION INDICATED THAT THE LEAD (SN (B)(4)) PASSED THE VISUAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. VISUAL INSPECTION WAS PERFORMED TO ENSURE THE DEVICE INTEGRITY. NO ANOMALIES WERE FOUND. DEVICE EVALUATION INDICATED THAT THE LEAD (SN (B)(4)) PHOTOGRAPHIC IMAGING TEST PERFORMED VISUAL INSPECTION CONFIRMED THAT ONE OF THE PADDLE ELECTRODES WAS SLIGHTLY BENT. ALL ELECTRODE WIRES WERE VERIFIED TO BE INTACT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-50, SERIAL/LOT #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM, MODEL #: SC-1110-02, SERIAL/LOT #: 233635, DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A PROCEDURE, THE PHYSICIAN NOTICED AN ACID BURN AT THE POCKET SITE; HOWEVER, HE COULD NOT DETERMINE IF THERE WAS LEAKAGE COMING FROM THE IPG. THE PHYSICIAN ALSO NOTICED THAT ONE OF THE CONTACTS CAME OFF THE PADDLE LEAD AND BELIEVED THE LEAD TO HAVE BEEN DAMAGED A LONG TIME AGO. THE PATIENT UNDERWENT EXPLANT OF THE IPG AND THE LEADS. THE PATIENT DID WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A PROCEDURE, THE PHYSICIAN NOTICED AN ACID BURN AT THE POCKET SITE; HOWEVER, HE COULD NOT DETERMINE IF THERE WAS LEAKAGE COMING FROM THE IPG. THE PHYSICIAN ALSO NOTICED THAT ONE OF THE CONTACTS CAME OFF THE PADDLE LEAD AND BELIEVED THE LEAD TO HAVE BEEN DAMAGED A LONG TIME AGO. THE PATIENT UNDERWENT EXPLANT OF THE IPG AND THE LEADS. THE PATIENT DID WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313023 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention