BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4243440 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21309
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37651, PRODUCT TYPE RECHARGER. PRODUCT ID: 37651 SERIAL# (B)(4), PRODUCT TYPE RECHARGER. PRODUCT ID: 3387S-40, LOT# VA05GWE , IMPLANTED: (B)(6)2013-PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# VA05GWE, IMPLANTED: (B)(6)2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(6), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708660, LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37651, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3387S-40, LOT# VA05GWE, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# VA05GWE, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A FAULTY CABLE ON THE RECHARGER. ACHIEVING COUPLING WITH THE TELEMETRY HEAD AND THE RC SEEMED DEPENDENT ON MANIPULATING THE CORD WHERE IT CONNECTED TO THE RECHARGING UNIT. IT WOULD DROP FROM 8 BARS TO 4 BY THE MANIPULATION OF THE GREY CORD AT THE PROXIMAL END. THE ISSUE CAUSED DIFFICULTY AND LENGTHY RECHARGING SESSIONS. THE RC APPARENTLY DEPLETED AND THE PATIENT¿S SYMPTOMS RETURNED BUT THEY WERE ABLE TO RECHARGE AND THE SYMPTOMS RESOLVED. A REPLACEMENT WAS REQUIRED AS A RESULT OF THE EVENT AND THE ISSUE WAS RESOLVED. THE RECHARGING COUPLING APPEARED TO BE MUCH EASIER. THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED ONE DAY LATER REPORTED THAT THEY HAD DIFFICULTY KEEPING THE COUPLING BARS. THE PROBLEM STARTED OVER THE WEEKEND AND THE PATIENT WAS LEFT WITH A DIFFERENT RECHARGER FOR THEM TO TRY THE DAY PRIOR TO REPORT. THE PATIENT STILL HAD PROBLEMS ONE DAY LATER. ON (B)(6) 2014 THE MANUFACTURER REPRESENTATIVE HAD NOT HEARD ANYTHING FURTHER FOR THE PATIENT SO THEY ¿ASSUMED THEY HAD GOTTEN THE HANG OF THINGS.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT UPON RETURN AND ANALYSIS OF THE RECHARGER ANALYSIS FOUND THE COMPLAINT WAS UNVERIFIED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS THE DEVICE THAT HAD DEPLETED WHICH WAS DUE TO THE PATIENT NOT RECHARGING PROPERLY. THE MANUFACTURING REPRESENTATIVE HAD NOT HEARD FROM THE PATIENT SINCE SWITCHING OUT THE CHARGER THAT THEY THOUGHT MAY HAVE BEEN FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725310 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00022 YR