BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4200991 · Received October 27, 2014

    Report

    Report Number
    3006630150-2014-02484
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION WHEREIN IPG WAS RE-SECURED IN THE POCKET SITE. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR THE IPG MOVING AROUND THE POCKET WAS BECAUSE THE SITE WAS TOO LARGE AND THE IPG CAME LOOSE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE IPG WOULD MOVE AROUND AND WAS NOT ANCHORED DOWN. IT WAS BELIEVED THAT IT WAS EITHER THE POCKET GOT STRETCHED OR DID NOT HEAL PROPERLY. X-RAYS WERE TAKEN AND CONFIRMED THAT THE IPG HAD NOT CHANGED FROM ITS ORIGINAL LOCATION. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE IPG WOULD MOVE AROUND AND WAS NOT ANCHORED DOWN. IT WAS BELIEVED THAT IT WAS EITHER THE POCKET GOT STRETCHED OR DID NOT HEAL PROPERLY. X-RAYS WERE TAKEN AND CONFIRMED THAT THE IPG HAD NOT CHANGED FROM ITS ORIGINAL LOCATION. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE IPG WOULD MOVE AROUND AND WAS NOT ANCHORED DOWN. IT WAS BELIEVED THAT IT WAS EITHER THE POCKET GOT STRETCHED OR DID NOT HEAL PROPERLY. X-RAYS WERE TAKEN AND CONFIRMED THAT THE IPG HAD NOT CHANGED FROM ITS ORIGINAL LOCATION. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683996 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention