BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1053250 · Received May 28, 2008

    Report

    Report Number
    3004209178-2008-02857
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 28, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Removal / Correction Number
    Z-0694-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. THE SERIAL NUMBER IS INCLUDED IN THE RANGE FOR THE LIFTED BONDWIRE (2007), REASON FOR RECALL HAS NOT BEEN CONFIRMED IN THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A POWER ON RESET CONDITION WITH THE INS. THE HCP WAS ABLE TO CLEAR AND REPROGRAM THE DEVICE. THE DEVICE WAS REPLACED. NO SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 Required Intervention LEAD MODEL 3387 LOT# J0437135V| IMPLANTED:| EXTENSION MODEL 7482 LOT# NHU063686V| IMPLANTABLE NEURO STIMUALTOR MODEL 7426| EXPLANTED:| EXTENSION MODEL 7482 LOT# NHU063685V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD MODEL 3387 LOT# J0428349V| EXPLANTED:| IMPLANTED:| LOT# NFW123142H| IMPLANTED:| EXPLANTED: