BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2212288 · Received August 15, 2011

    Report

    Report Number
    3006630150-2011-01289
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN REVISED PATIENT'S POCKET AND MOVED THE IPG CLOSER TO THE SURFACE. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING HER IPG. THE PHYSICIAN CONFIRMED THAT HE INTENTIONALLY BURIED THE IPG TOO DEEP AS THE FAT TISSUE BETWEEN THE IPG AND THE OUTER SKIN WOULD BREAK DOWN AND THE POCKET WOULD BECOME SHALLOW ON ITS OWN. THE BSN SALES REPRESENTATIVE FOLLOWED UP WITH PATIENT WHO REPORTED SHE WAS STILL HAVING DIFFICULTY CHARGING. THE PHYSICIAN HAS RECOMMENDED A POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING HER IPG. THE PHYSICIAN CONFIRMED THAT HE INTENTIONALLY BURIED THE IPG TOO DEEP AS THE FAT TISSUE BETWEEN THE IPG AND THE OUTER SKIN WOULD BREAK DOWN AND THE POCKET WOULD BECOME SHALLOW ON ITS OWN. THE BSN SALES REPRESENTATIVE FOLLOWED UP WITH PATIENT WHO REPORTED SHE WAS STILL HAVING DIFFICULTY CHARGING. THE PHYSICIAN HAS RECOMMENDED 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention