BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2191075 · Received July 29, 2011

    Report

    Report Number
    3007566237-2011-05871
    Event Type
    Injury
    Date Received
    July 29, 2011
    Report Date
    July 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Removal / Correction Number
    Z-500-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS INCLUDED IN THE MEDICAL DEVICE SAFETY ALERT, FOR THE MODEL 3550-39 TITAN ANCHOR DUE TO THE POTENTIAL FOR LEAD MIGRATION AS A RESULT OF INSERT SEPARATION WITHIN THE ANCHOR, PHYSICIAN COMMUNICATION ((B)(6) 2009). ANALYSIS OF THE TITAN ANCHOR (MODEL 3550-39) FOUND THE TITANIUM INSERT WAS SEPARATED FROM THE SILICONE SLEEVE. BREACHED CUTS WERE OBSERVED ON THE SLEEVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION TO REPOSITION A LEAD, THE PHYSICIAN NOTED THAT THE METAL PART OF THE TITAN ANCHOR HAD COME LOOSE FROM ITS SHEATH. THE TITAN ANCHOR WAS EXPLANTED AND WAS NOT REPLACED. THE PT INCURRED NO INJURY AND RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| STIM ACCESSORY: MODEL 3550-39, LOT# UNK