BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1931414 · Received December 15, 2010

    Report

    Report Number
    3006630150-2010-02098
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT HAD STOPPED USING HIS STIMULATION AFTER A SHOULDER SURGERY. REPROGRAMMING WAS UNSUCCESSFUL AS STIMULATION DID NOT COVER THE PAIN AREAS IN THE PT'S RIGHT ARM AND IRRITATED PT'S "FROZEN SHOULDER". THE PHYSICIAN NOTICED REDNESS AT THE EXTENSION SITE AND REFERRED THE PT TO A PAIN PHYSICIAN. THE PT ALSO EXPERIENCED A BURNING SENSATION AT THE EXTENSION SITE. DURING A LEAD REVISION SURGERY DUE TO MIGRATION, THE PHYSICIAN EXPLANTED THE IPG, 3 EXTENSIONS, AND ONE LEAD DUE TO THE COMPLAINT OF THE BURNING SENSATION AT THE EXTENSION SITE. THE PHYSICIAN INDICATED THAT MEDICAL ADHESIVE WAS USED AT THE TIP OF THE EXTENSION DURING THE INITIAL IMPLANT THAT MAY HAVE CAUSED THE CURRENT TO BLEED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention LEAD EXTENSION, 35CM, MODEL#: SC-3138-30| (B)(4)| (B)(4)| (B)(4)| (B)(4)| MODEL#: SC-1110| IMPLANTABLE PULSE GENERATOR (IPG)