BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XTREL

    MDR report key: 2250609 · Received September 9, 2011

    Report

    Report Number
    3007566237-2011-07681
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 17, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RECEIVER MODEL 3470, SERIAL (B)(4) FOUND NO SIGNIFICANT ANOMALIES. THERE WERE SPOTS OF DISCOLORATION ON THE CAN AND PINS. THE RETAINER, EPOXY, ADHESIVE BEAD, ACCESS HOLE ADHESIVE, CONNECTOR MODULE AND SETSCREWS WERE OK. THERE WAS A SMALL PUNCHOUT HOLE IN THE #1 SETSCREW GROMMET. THERE WAS FOREIGN MATERIAL IN THE PORTS. THE CONNECTION WAS GOOD BUT THE CONNECTOR LEGS OF THE EXTENSION WERE SEVERELY STRETCHED. THERE WAS GOOD STABLE OUTPUT FROM THE INS TO THE CUT EXTENSION. THERE WAS A SHORT BETWEEN CIRCUITS #0 AND #3 AND #1 AND #2. ANALYSIS OF THE EXTENSION MODEL 7495-51 SERIAL (B)(4) FOUND NO SIGNIFICANT ANOMALIES. THE PROXIMAL SEGMENT WAS RETURNED AND THE CONNECTOR LEGS OF THE EXTENSION WERE SEVERELY STRETCHED EXPOSING THE CONNECTOR WIRES AND CAUSING THEM TO SHORT TOGETHER. THIS WAS CAUSED BY OVERSTRESS / EXPLANT DAMAGE. SETSCREW MARKS WERE IN THE CORRECT LOCATION. ALL THE CONDUCTORS WERE CUT THROUGH. THE DISTAL END WAS NOT RETURNED. CONTINUITY WAS ACCEPTABLE. THERE WAS A SHORT BETWEEN CIRCUITS #0 AND #3 AND #1 AND #2 DUE TO THE STRETCHING OF THE CONNECTOR LEGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S IMPLANTABLE NEUROSTIMULATOR WAS EXPLANTED ON (B)(6) 2011 DUE TO AN ABSCESS ON THE BACK. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XTREL LGW MEDTRONIC NEUROMODULATION 3470 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION: MODEL 7495-51, LOT # XR0038585N| EXPLANTED:| IMPLANTED: