BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5184677 · Received October 28, 2015

    Report

    Report Number
    3004209178-2015-21694
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Report Date
    October 1, 2015
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37761, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER; PRODUCT ID 37761, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER; PRODUCT ID 3387S-40, LOT# V113842, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V106048, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER CARE TAKER REPORTED THAT THE PATIENT HAD CEREBRAL PALSY AND DYSTONIA. THE PATIENT WAS IN THE WHEELCHAIR. THE CARETAKER WAS TRYING TO HELP THE PATIENT COMMUNICATE. A BROKEN CONNECTOR PIN ON THE DESKTOP CHARGER WAS NOTED. THE PATIENT REPORTED THAT HER WHOLE RECHARGING SYSTEM WAS NOT WORKING AND SHE WAS NOT ABLE TO CHARGE BUT SHE USED IT ALL THE TIME. THE PATIENT DID NOT HAVE THE PATIENT PROGRAMMER ON THE DAY OF REPORT. THE PATIENT WAS NOT ABLE TO EXPLAIN WHAT THE PROBLEM WAS. THE CARETAKER USED PATIENT'S EQUIPMENT ON THE CALL, HE PLUGGED INTO THE DESKTOP CHARGER BUT HE WAS NOT ABLE TO INSERT THE CONNECTOR PIN. HE REPORTED IT DID NOT FIT INTO THE INSR (IMPLANTABLE NEUROSTIMULATOR RECHARGER). IT WAS INDICATED THAT THE PATIENT HAD SPEECH IMPAIRMENT AND WAS VERY DIFFICULT TO UNDERSTAND. IT WAS FURTHER REPORTED THAT THE INS (IMPLANTABLE NEUROSTIMULATOR) HAD BEEN DEPLETED SINCE (B)(6) 2014. NO PATIENT SYMPTOMS OR HARM WERE REPORTED. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716514 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1