BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5172746 · Received October 24, 2015

    Report

    Report Number
    3004209178-2015-21338
    Event Type
    Injury
    Date Received
    October 24, 2015
    Report Date
    September 30, 2015
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V911922, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V931137, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP) AND MANUFACTURE REPRESENTATIVE THAT REPORTED THERE WAS A DAMAGED EXTENSION. THE PATIENT COMPLAINED OF HER CHEST BEING SHOCKED WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED. THE INS WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE PATIENT WAS HAVING ELECTRICAL SHOCKS IN THE INS CHEST POCKET. IT WAS INITIALLY ASSUMED THAT THERE WAS AN ELECTRICAL LEAK FROM THE INS. WHEN THEY REPLACED THE INS ON THE DAY OF REPORT, AN IMPEDANCE CHECK WAS PERFORMED. THE IMPEDANCES WERE ALL HIGH ON THE RIGHT SIDE EXCEPT FOR CONTACT 8. THE OTHER PORT WAS TRIED AND THE IMPEDANCES STILL REMAINED HIGH. IT WAS THEN NOTICED THAT PART OF THE EXTENSION, ABOUT TWO INCHES FROM THE END, LOOKED SCUFFED. AFTER MORE OBSERVATION IT WAS DETERMINED THAT THE EXTENSION WAS DAMAGED SOMEHOW. THE INS WAS REPLACED BUT NO FURTHER ACTION HAD BEEN TAKEN YET. ONE CONTACT REMAINED INTACT AND THEY WOULD TRY TO PROGRAM AROUND THE DAMAGED EXTENSION. THE PATIENT WAS IMPLANTED FOR DYSTONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704175 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention