BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2961953 · Received February 14, 2013

    Report

    Report Number
    3007566237-2013-00484
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    February 1, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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 NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: EXTENSION: PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: EXTENSION: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3387-40, LOT# J0555189V. PRODUCT TYPE: LEAD: PRODUCT ID 3387-40, LOT# J0555189V, IMPLANTED: (B)(6) 2005. PRODUCT TYPE: LEAD. THE MANUFACTURING SITE ID WAS PREVIOUSLY REPORTED AS #(B)(4). ADDITIONAL REVIEW INDICATES THE CORRECT MANUFACTURING SITE ID IS #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDUCED LONGEVITY IN BATTERY LIFE WHEN MODELS OF HIS IMPLANTABLE NEUROSTIMULATOR WERE CHANGED. THE PATIENT WAS ON HIS 7TH BATTERY REPLACEMENT AT THE TIME OF MODEL CHANGE AND DECREASE IN LONGEVITY. CALLER STATED SHE THINKS THE PATIENT'S BATTERY LIFE WENT FROM "13 MONTHS TO 11 MONTHS." ADDITIONAL INFORMATION HAS BEEN REQUESTED AND A SUPPLEMENTAL REPORT WILL BE FILED IF INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN ERI (ELECTIVE REPLACEMENT INDICATOR) MESSAGE OCCURRED ON (B)(6) 2012 AND A LONGEVITY CALCULATION WAS DONE USING THE PATIENT'S SETTINGS. IT WAS REPORTED THAT THE LONGEVITY CALCULATION MATCHED THE DEVICE BATTERY DRAIN. ERI WAS ESTIMATED TO BE 8.7 MONTHS, AND EOS (END OF SERVICE) WAS ESTIMATED TO BE 11.7 MONTHS. IT WAS REPORTED THAT A RECHARGEABLE DEVICE WAS BEING CONSIDERED FOR THE PATIENT INSTEAD OF THE PATIENT'S CURRENT NON-RECHARGEABLE MODEL. IT WAS ALSO NOTED THAT THE PATIENT'S PREVIOUS DEVICE MODEL HAD A LONGEVITY ESTIMATE OF 12 MONTHS BASED ON THE PATIENT'S SETTINGS. THE PATIENT'S DEVICE WAS EXPLANTED AND REPLACED. IT WAS LATER REPORTED AFTER THE PATIENT'S DEVICE REPLACEMENT THAT THE PATIENT WAS VERY HAPPY WITH THE SYSTEM AND THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65608 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1