BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3320255 · Received August 30, 2013

    Report

    Report Number
    3004209178-2013-15524
    Event Type
    Malfunction
    Date Received
    August 30, 2013
    Report Date
    August 6, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT # V012773, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) TURNED OFF DUE TO A MAGNETIC FIELD. THE PATIENT HAD REPLACEMENT SURGERY TO REPLACE THE LEFT INS. THE RIGHT INS WAS ¿TURNED OFF AND ZEROED OUT¿ PRIOR TO THE SURGERY. THE INS (RIGHT) WAS REPROGRAMMED AND TURNED ON AFTER THE LEFT INS WAS REPLACED ON (B)(6) 2013. THE PATIENT CALLED HIS HEALTHCARE PROVIDER (HCP) LATER AND STATED THAT HIS RIGHT INS WAS NOT TURNED ON AFTER THE LEFT INS WAS REPLACED. THE MANUFACTURER REPRESENTATIVE HAD DOCUMENTATION TO SUPPORT THAT THE PATIENT¿S RIGHT INS WAS TURNED OFF PRIOR TO THE SURGERY AND TURNED BACK ON POST-SURGERY. THE PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF. WHEN THE PATIENT SAW THAT HIS RIGHT INS WAS OFF, HE TURNED IT BACK ON WITH THE PATIENT PROGRAMMER.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE CAUSE OR SOURCE OF THE MAGNETIC FIELD COULD NOT BE DETERMINED. THE PATIENT WAS REPORTED AS DOING WELL. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429091 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1