BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2945569 · Received February 6, 2013

    Report

    Report Number
    3004209178-2013-01348
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3387S-40, LOT# VA04NKA, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID: 3387S-40, LOT# VA02KCE, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE WAS PROGRAMMED ABOUT 5 DAYS PRIOR TO THE DAY OF REPORT. THE PATIENT FELT A LITTLE BETTER AFTER THE PROGRAMMING. THE PATIENT'S "BIGGEST PROBLEM" WAS THAT HE DIDN'T SLEEP WELL AND HAD PAIN IN HIS BACK. THE PATIENT SLEPT WELL THE FIRST 3 NIGHTS AFTER GETTING PROGRAMMED, THEN "ALL OF A SUDDEN, HE KIND OF WENT BACK TO HIS OLD WAYS OF NOT SLEEPING GREAT." THE PATIENT HAD SENSITIVE AND TINGLING FEET THAT STARTED THE DAY PRIOR TO REPORT. IT WAS REPORTED THE PATIENT USED "TV EARS" EVERY MORNING, AND THE REPORTER WONDERED WHETHER THE TV EARS AFFECTED THE DEVICE, AS PART OF THE TV EARS HUNG DOWN TO NEAR WHERE THE IMPLANTABLE NEUROSTIMULATORS WERE IMPLANTED IN THE CHEST. AT THE TIME OF REPORT THE PATIENT TURNED OFF THE IMPLANTABLE NEUROSTIMULATOR AND DID NOT NOTICE A CHANGE IN THERAPY. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR FEBRUARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49627 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1