BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4132919 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18101
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V754185, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V763711, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER REPLACEMENT THERE WAS A LOW IMPEDANCE READING. THE ELECTRODE COMBINATION OF 2 AND 3 WAS 127 OHMS. THE CAUSE OF THE SHORT CIRCUIT WAS NOT DETERMINED. THE OUT OF RANGE IMPEDANCE DID NOT AFFECT THERAPY OR THE PROGRAMMED CONFIGURATIONS. THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY. REFER TO MANUFACTURING REPORT #3004209178-2013-20846 AS THE PATIENT HAD ISSUES PRIOR TO REPLACEMENT. REFER TO MANUFACTURING REPORT #3004209178-2014-18089 AS THE PATIENT HAD ISSUES DURING REPLACEMENT AND AN INS WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612827 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR