BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8638015 · Received May 23, 2019

    Report

    Report Number
    3004209178-2019-10193
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 5, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387-40, IMPLANTED: UNKNOWN ((B)(6) 2006 AND A RE-IMPLANT OF ONE SIDE ON (B)(6) 2008) PRODUCT TYPE: LEAD; PRODUCT ID: 748251, IMPLANTED: UNKNOWN ((B)(6) 2006 AND A RE-IMPLANT OF ONE SIDE ON (B)(6) 2008), PRODUCT TYPE: EXTENSION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER EITHER (B)(4). OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387-40, LOT# UNKNOWN (EITHER: B0744243K, V003964, OR V003450), PRODUCT TYPE: LEAD; PRODUCT ID: 748251, SERIAL# UNKNOWN (EITHER: (B)(4)), PRODUCT TYPE: EXTENSION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD LOW IMPEDANCE FOR ALL BIPOLAR ELECTRODE COMBINATIONS ON THEIR RIGHT SIDE. NO KNOWN ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS LED TO THE EVENT, AND NO DIAGNOSTICS OR TROUBLESHOOTING WERE PERFORMED. SURGICAL INTERVENTION OCCURRED TO REPLACE THE DEPLETED INS BATTERY. CONTACTS WERE CLEANED AND THE INS WAS REPLACED, HOWEVER THIS DID NOT RESOLVE THE SHORT CIRCUITS FOR ALL BIPOLAR ELECTRODES. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. THE CAUSE HAD NOT BEEN DETERMINED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430596 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR