BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1161190 · Received September 15, 2008

    Report

    Report Number
    3004209178-2008-05736
    Event Type
    Injury
    Date Received
    September 15, 2008
    Report Date
    August 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED 1 OF 5 CASES OF DEEP BRAIN STIMULATION LEAD MALFUNCTION AND/OR LEAD FRACTURE. NO PATIENT SYMPTOMS, OR OUTCOME WERE REPORTED. NO DEVICE TROUBLESHOOTING WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PLEASE SEE MFR. REPORT # 300420917820084828.

    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 IMPLANTED:| EXPLANTED:| EXTENSION MODEL 7482 LOT# NHU094534V| IMPLANTABLE NEURO STIMULATOR MODEL 7426| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION MODEL 7482 LOT# NHU160209V| EXPLANTED:| LOT# NFW147773H| IMPLANTED:| LEAD MODEL 3389 LOT# V046231| EXPLANTED:| LEAD MODEL 3387 LOT# J0417922V| IMPLANTED:| PROGRAMMER MODEL UNK LOT# UNK