BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3073299 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06778
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 10, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 64002, LOT# N248026, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387S-40, LOT# V071747, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V054407, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 64002, LOT# N248026, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: ADAPTER: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37651, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS IN OVERDISCHARGE (OD). THE PATIENT HAD BEEN IN OD FOR 2 YEARS BECAUSE OF SUBSTANCE ABUSE. THE PATIENT WAS AN ALCOHOLIC AND USED ALCOHOL TO RESOLVE HIS ESSENTIAL TREMOR INSTEAD OF STIMULATION. THE PATIENT WAS CURRENTLY IN REHAB AND WANTED TO USE THE STIMULATION SYSTEM AGAIN. IT WAS FURTHER REPORTED THAT A PHYSICIAN MODE RECHARGE (PMR) WAS COMPLETED. THE NORMAL CHARGING SCREEN WAS RECEIVED. THE PATIENT HAD 2-6 COUPLING BARS. FURTHER INFORMATION INDICATED THAT A POWER ON RESET (POR) OCCURRED AND WAS CLEARED. AFTER CHARGING SOME AND CLEARING THE POR UPON INTERROGATION, THE DEVICE INDICATED IT WAS DISCHARGED. AN IMPEDANCE TEST WAS NORMAL. THE PATIENT WAS INSTRUCTED TO KEEP CHARGING TO EXERCISE THE BATTERY AND TO PREVENT A SECOND OD. THE PATIENT NOTED DISSATISFACTION AND SIDE EFFECTS AS PRIMARY REASON FOR NOT CHARGING FOR 2 YEARS. THE PLAN WAS TO TURN THE STIMULATION BACK ON AT THE NEXT NEUROLOGY APPOINTMENT. ADDITIONAL INFORMATION WAS REQUESTED; IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION CONFIRMED THAT THE PATIENT¿S RECHARGEABLE INS MODEL WAS REPLACED WITH A PRIME CELL MODEL ON (B)(6) 2013. THE PATIENT WAS REPORTED AS DOING WELL AND RECEIVING EFFECTIVE THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE STIMULATOR WOULD NOT HOLD A CHARGE. THE STIMULATOR WOULD DROP TO 0% AS SOON AS A CLINICIAN PROGRAMMER WAS ATTEMPTED. THE PATIENT CHARGED TO 100% THREE TIMES AND WITHIN AN HOUR IT WOULD DROPBACK DOWN TO 25%. THE PATIENT WILL HAVE HIS STIMULATOR REPLACED ON (B)(6) 2013. ADDITIONAL INFORMATION WAS REQUESTED; IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173281 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention