BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2031944 · Received March 28, 2011

    Report

    Report Number
    3006630150-2011-00398
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SHOULD BE OMITTED FROM THIS FIELD. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD ORIGINALLY CLAIMED SHE FELT A PRESSURE IN HER HIP AREA AT THE IPG SITE AND WAS UNABLE TO CHARGE. ON THE DAY OF THE SURGERY THE BSN SALES REPRESENTATIVE DISCOVERED THAT THERE WERE TWO BARS ON THE REMOTE. THE IPG APPEARED TO BE WORKING PROPERLY. THE PATIENT THEN COUNTERED THE ORIGINAL COMPLAINT AND REPORTED BEING ABLE TO CHARGE SINCE BEING IMPLANTED AND DEMANDED THAT A SECOND LEAD BE PUT IN BECAUSE SHE WOULD LIKE THE STIMULATION TO COVER HIGHER IN HER NECK BECAUSE WHEN HER PAIN EXTENDED INTO THE UPPER NECK. DURING THE PROCEDURE, THE PHYSICIAN DISCOVERED THAT THE BATTERY HAD NOT FLIPPED AND THE X-RAY WAS READ INCORRECTLY. THE PHYSICIAN REMOVED AND RE-IMPLANTED THE IPG AFTER IMPLANTING THE SECOND LEAD.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HIT THE SIDE OF HER BED WHILE SLEEPING AND WOKE UP WITH PRESSURE AT THE IPG SITE AND COULD NOT CHARGE THE IPG. AN X-RAY WAS TAKEN AND CONFIRMED THAT THE IPG WAS FLIPPED. THE PATIENT WILL UNDERGO A POCKET REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HIT THE SIDE OF HER BED WHILE SLEEPING AND WOKE UP WITH PRESSURE AT THE IPG SITE AND COULD NOT CHARGE THE IPG. AN X-RAY WAS TAKEN AND CONFIRMED THAT THE IPG WAS FLIPPED. THE PATIENT WILL UNDERGO A POCKET REVISION PROCEDURE.

    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