BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3062092 · Received April 16, 2013

    Report

    Report Number
    3006630150-2013-00742
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    February 8, 2012
    Report Date
    February 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL AND PERFORMANCE TESTS PERFORMED. THE COMPLAINT ABOUT THE DIFFICULTY CHARGING IPG WAS NOT VERIFIED. IN THE LAB, THE IPG WAS CHARGED 3.77 VOLTS IN ONE CYCLE FROM ITS HIBERNATION. THE PROFILE DATA SHOWED THAT THE IPG HAD BEEN NORMALLY CHARGED FULLY. THE POSSIBILITY THAT ELECTRICAL LEAKAGE COULD CAUSE THE POCKET PAIN WAS INVESTIGATED. CURRENT LEAKAGE TESTS VERIFIED NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE. RESIDUAL GAS ANALYSIS VERIFIED THAT THE DEVICE INSULATION HAD NOT BEEN COMPROMISED. REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION WHEREIN THE IPG WAS REPLACED. THE PATIENT HAD THE IPG FOR NINE YEARS AND WOULD NO LONGER HOLD A CHARGE. NO MALFUNCTION SUSPECTED. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AND SORENESS AT THE POCKET SITE. THE PATIENT WILL UNDERGO A POCKET REVISION, BUT NO FURTHER ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AND SORENESS AT THE POCKET SITE. THE PATIENT WILL UNDERGO A POCKET REVISION, BUT NO FURTHER ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AND SORENESS AT THE POCKET SITE. THE PATIENT WILL UNDERGO A POCKET REVISION, BUT NO FURTHER ACTION WILL BE TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162784 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention