BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2861685 · Received December 7, 2012

    Report

    Report Number
    3006630150-2012-02269
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION. DURING THE PROCEDURE IT WAS DETERMINED THAT THE POCKET OPENED AS THE PATIENT'S SKIN WAS TAUT IN THAT LOCATION AND THERE WAS A LOT OF FATTY TISSUE. THE POCKET WAS MOVED SLIGHTLY MORE LATERALLY AND SUPERIOR TO A MORE FATTY LOCATION. THE PATIENT WAS REPORTEDLY DOING FINE FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD OOZING AND TENDERNESS AT THE POCKET SITE. IT WAS DETERMINED THAT THE PATIENT WAS BENDING TOO MUCH THAT THE INCISION AT THE IPG SITE REOPENED. THE PHYSICIAN BELIEVED THAT THE EVENT WAS NON-DEVICE RELATED AND THAT INFECTION MIGHT BE PRESENT BUT THE PATIENT WAS NOT HAVING FEVER. THE SITE WAS CLEANED AND THE PATIENT WAS GIVEN ANTIBIOTICS. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD OOZING AND TENDERNESS AT THE POCKET SITE. IT WAS DETERMINED THAT THE PATIENT WAS BENDING TOO MUCH THAT THE INCISION AT THE IPG SITE REOPENED. THE PHYSICIAN BELIEVED THAT THE EVENT WAS NON-DEVICE RELATED AND THAT INFECTION MIGHT BE PRESENT BUT THE PATIENT WAS NOT HAVING FEVER. THE SITE WAS CLEANED AND THE PATIENT WAS GIVEN ANTIBIOTICS. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention