BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4377933 · Received January 2, 2015

    Report

    Report Number
    3004209178-2015-00065
    Event Type
    Malfunction
    Date Received
    January 2, 2015
    Date of Event
    December 10, 2014
    Report Date
    December 12, 2014
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT # VA08KLN, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT # V233444, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 7438, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT # V233444, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) IN THEIR UPPER LEFT CHEST FOR THE RIGHT SIDE OF THEIR BODY. FOR THE LAST COUPLE OF DAYS THE PATIENT¿S RIGHT ARM HAD BEEN SHAKING. THE REPORTER STATED THE IMPLANT NEAR THE RIGHT COLLAR BONE DID NOT WORK BECAUSE IT WAS IN THE WRONG SPOT IN THE PATIENT¿S BRAIN SO IT DID NOT WORK. IT HAD NOT WORKED FOR A WHILE SO IT WAS NOT ON. THE REPORTER STATED THEY PUT IT IN THE WRONG SPOT IN THE BRAIN. THE INS WAS ON AND THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR