BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1408461 · Received December 23, 2008

    Report

    Report Number
    3004209178-2008-08538
    Event Type
    Malfunction
    Date Received
    December 23, 2008
    Date of Event
    December 1, 2008
    Report Date
    December 1, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, A POWER ON RESET (POR) CONDITION OCCURRED. THE PT HAD A RETURN OF SYMPTOMS. THERE WAS NO EXPLANATION FOR THE EVENT. INSTRUCTIONS WERE GIVEN TO ISOLATE THE RIGHT STIMULATOR BEING TURNED OFF. IT WAS ALSO REPORTED, THE PT'S BILATERAL STIMULATORS WERE IMPLANTED ONLY THREE INCHES APART AND SOME PROGRAMMING CROSSTALK HAD OCCURRED DUE TO THIS (REFER TO MEDWATCH REPORT #2004209178-2008-08536). THE CROSSTALK HAD EXISTED BOTH PRE AND POST STIMULATOR REPLACEMENT. THE STIMULATOR LOCATION WAS NOT ALTERED AT REPLACEMENT TIME. THE STIMULATOR POCKETS WILL HAVE TO BE REVISED TO AVOID THIS. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR LEAD: MODEL 3389| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482| LOT# NFW145663H| EXPLANTED:| LEAD: MODEL 3389| EXPLANTED:| EXTENSION: MODEL 7482| IMPLANTABLE NEURO STIMULATOR: MODEL 7426