BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA RC

    MDR report key: 1901900 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-09368
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    July 19, 2010
    Report Date
    October 26, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO REPORTING, THE PT HAD HER INS REPLACED DUE TO POSSIBLE DEFECTIVE BATTERY. PT HAD ORIGINALLY RECEIVED GOOD TREMOR CONTROL AND WAS RECHARGING THE SYSTEM EVERY 5-6 DAYS. SHE FOUND IT VERY EASY TO RECHARGE THE SYSTEM. PT BEGAN TO NOTICE LESS TREMOR CONTROL AND HAVING TO CHARGE THE UNIT EVERY DAY OVER SEVERAL HOURS. SEVERAL ADJUSTMENTS WERE TRIED BY THE HCP BUT THE PROBLEM CONTINUED. DURING DEVICE INTERROGATION A SHORT ON HER COMBINATION OF 0+, 1- WAS NOTED. ANOTHER COMBINATION WAS TRIED WITH LESS TREMOR CONTROL. THE "SHORT" WAS NOTED TO BE INTERMITTENT. HCP DECIDED TO DO EXPLORATORY SURGERY AND PROBABLE REVISION OF THE ADAPTOR OR EXTENSION. AFTER TESTING THE LEAD AND EXTENSIONS IMPEDANCES WERE NORMAL. THE ADAPTOR WAS REPLACED AND STILL SHOWED A SHORT AT 0+, 1-. HCP DECIDED TO CHANGE OUT THE INS, HE WAS WORRIED ABOUT HAVING TO DO ANOTHER SURGERY WITH PT'S HISTORY OF POST OP INFECTIONS. THIS PRODUCED NORMAL IMPEDANCE VALUES. SINCE THAT TIME PT HAS EXCELLENT TREMOR CONTROL, BUT COMPLAINS OF THE LENGTH OF TIME IT TAKES TO RECHARGE AND THE ABILITY TO GET GOOD COUPLING. PT WAS SEEN BY HCP AND BATTERY SITE APPEARS "SMOOTH", NO SIGN OF EXTENSION WIRES COVERING THE BATTERY. MEDTRONIC TECH SUPPORT HAS SUGGESTED SEVERAL WAYS TO IMPROVE COUPLING, BUT NOTHING HAS BEEN SUCCESSFUL. MEDTRONIC REP IS TRYING TO SET UP AN APPOINTMENT WITH THE PT TO FURTHER EVALUATE THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA RC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37612 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention EXPLANTED:| LEAD: MODEL 3387, LOT# J0343679V| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL009167P| LOT# NFW118932H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| EXPLANTED:| IMPLANTED:| LOT# NFW118968H| EXPLANTED:| ADAPTER: MODEL 64001, LOT# N245780| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# J0340435V| IMPLANTABLE NEURO STIMULATOR: MODEL 37612,| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU030591V| IMPLANTED:| LOT# NKG701610H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| EXTENSION: MODEL 7482, LOT# NHU030109V| IMPLANTED:| EXPLANTED:| IMPLANTED: