BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2616975 · Received June 14, 2012

    Report

    Report Number
    3004209178-2012-04507
    Event Type
    Malfunction
    Date Received
    June 14, 2012
    Report Date
    May 22, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748240, SERIAL# (B)(4)L IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT# V002272, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE TELEMETRY ISSUES. THE HEALTH PROFESSIONAL CLAIMS THAT THE IMPLANTABLE NEUROSTIMULATOR WAS NOT WORKING, WHICH RESULTED IN A LOSS OF THERAPEUTIC EFFECT. THERE WERE MULTIPLE COMMUNICATION ATTEMPTS USING THE CLINICIAN PROGRAMMER. XRAYS SHOWED THE DEVICE WAS NOT FLIPPED. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS THAT THE BATTERY WAS ASSUMED TO BE AT END OF LIFE AS 'NOTHING REGISTERED.' IT WAS UNKNOWN IF THE BATTERY DEPLETION WAS NORMAL. THE PATIENT DID NOT WANT TO HAVE ANY FURTHER ACTION DONE AT THE TIME. THE PATIENT OUTCOME WAS NOTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1