BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SPINAL CORD STIMULATOR

    MDR report key: 1630449 · Received March 9, 2010

    Report

    Report Number
    3007566237-2010-01935
    Event Type
    Injury
    Date Received
    March 9, 2010
    Date of Event
    February 10, 2010
    Report Date
    February 10, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THE DEVICE IS INCLUDED IN THE MEDICAL DEVICE SAFETY, TITAN ANCHOR FIELD ACTION, PHYSICIAN COMMUNICATION (10/27/2009).

    Description of Event or Problem · 1

    FOUR MONTHS AFTER IMPLANT, THE PT EXPERIENCED A LOSS OF PARESTHESIA IN HER LEFT SIDE. THE LEFT LEAD HAD DISLODGED OUT OF THE EPIDURAL SPACE. THE PT WAS SENT TO THE OPERATING ROOM IN ORDER TO ATTEMPT LEAD REPOSITIONING OR REPLACE IT IF NEEDED. DURING THE PROCEDURE, THE IMPLANTERS SAW THAT THE LEFT TITAN METAL INSERT HAD SEPARATED FROM THE SILICONE PIECE. THE LEAD WAS REPLACED AND FIXED WITH A NEW TITAN. THE RIGHT SIDE TITAN WAS EXPLANTED AND A NEW TITAN RE-ANCHORED THE RIGHT LEAD. THE IMPLANTER THREW THE TITANS AWAY. NO SURGICAL COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EXPLANTED:| LEAD: MODEL UNK, LOT#: UNK| EXPLANTED:| IMPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT#: B0946543K