BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3524776 · Received December 18, 2013

    Report

    Report Number
    3004209178-2013-23683
    Event Type
    Injury
    Date Received
    December 18, 2013
    Report Date
    December 2, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40 LOT# V020895, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3387S-40 LOT# V020895, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 64002 LOT# N351566, IMPLANTED: 2013 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37651, SERIAL# (B)(4); PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED AND MOVED HIGHER ON (B)(6). THE PATIENT¿S BATTERY HAD MOVED AND SHE WAS NOT ABLE TO RECHARGE. IT WAS REPORTED THE PATIENT WAS ALLERGIC TO THE TAPE THEY PUT ON AFTER THE SURGERY; THEY PUT GAUZE WITH JUST A LITTLE TAPE OF IT AND THEY ALSO BRUISED THE PATIENT¿S BREAST DURING THE IMPLANT. THE DAY AFTER SURGERY, THE PATIENT TRIED RECHARGING BUT SHE DID NOT CHECK TO SEE IF THE INS WAS ON. ON THE DATE OF THIS REPORT THE PATIENT SAW HER DEVICE WAS ¿OFF ¿ OK,¿ BUT SHE WANTED TO SEE IT ON. THE PATIENT HAD BEEN TOLD TO CALL HER DOCTOR¿S NURSE. IT WAS NOTED THE PATIENT WAS IMPLANTED BECAUSE SHE HAD ¿REAL BAD¿ SEIZURES; SHE DID NOT HAVE TREMBLING OR SHAKING AND SHE DID NOT HAVE EVERY DAY OCCURRENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATES INFORMATION REPORTED PREVIOUSLY IN MANUFACTURER'S REPORT #3004209178-2013-23683 PERTAINS TO MANUFACTURER¿S REPORT #3004209178-2013-23683.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATES INFORMATION REPORTED PREVIOUSLY IN MANUFACTURER'S REPORT #3004209178-2013-23683 PERTAINS TO MANUFACTURER'S REPORT #3004209178-2013-16427.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661441 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention