BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA RC

    MDR report key: 2081466 · Received April 20, 2011

    Report

    Report Number
    3004209178-2011-02946
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REC'D INFO THE PT FELT HE WAS RECHARGING MORE THAN EXPECTED. THE RECHARGE INTERVALS WERE REVIEWED AND SEEMED TO BE APPROPRIATE. PT RECHARGES 1-2 TIMES/DAY AND TYPICALLY RECHARGES TO 100%. IMPEDANCES WERE CHECKED AND OUT-OF-RANGE WERE FOUND ON COMBINATIONS WITH 2 AND 3, NEITHER OF WHICH ARE PROGRAMMED. PT REPORTS THAT SINCE HE REC'D A NEW "BELT" IN (B)(6), HE HAS SEEN THAT THE INS DEPLETES MORE RAPIDLY THAN BEFORE. ADD'L INFO FROM THE HCP STATED THE PT HAS NOT GOTTEN WORSE OR HAD INCREASE IN SYMPTOMS. ACTUALLY HE IS DOING BETTER. ACTUALLY TO AVOID "DEVELOPMENT OF TOLERANCE" THE PT THINKS HE WAS HAVING LAST YR-ABOUT 6 MONTHS AGO-THE HCP GAVE THE PT GROUPS TO CHANGE BACK AND FORTH ON. BECAUSE OF THAT, HE ALSO LOWERED THE VOLTAGE SETTINGS. HE HAS INCREASED THE PW THOUGH, AND/OR CHANGED THE ELECTRODE CONFIGURATIONS A BIT. HE DOESN'T RECALL IF HE'S ADDED AN ELECTRODE (SINCE NOW WE SEE 2 NEGATIVE ELECTRODES). HE SAID HE DOESN'T USE ELECTRODE 2 OR 3 BECAUSE HE DIDN'T SEE EFFICACY FROM THEM. THE PT'S ONLY COMPLAIN TO THE DOCTOR HAS BEEN ABOUT DISCOMFORT, NOTHING TO DO WITH RECHARGING. IT MAY BE DISCOMFORT DUE TO THE RECHARGER BELT, WHICH THE PT DID MENTION. THE HCP DID TRY TO CHANGE THE STIMULATION OF THE CASE (AND MAKE 3+), BUT THAT DIDN'T WORK FOR THE PT'S CLINICAL SYMPTOMS. WHEN HE DROPPED THE VOLTAGE, PT SAID THE DISCOMFORT GOT BETTER. HCP WILL REASSURE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA RC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37612 H0230078

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR LEAD: MODEL 3387, LOT# V279759| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# V227370