BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4908486 · Received July 13, 2015

    Report

    Report Number
    3004209178-2015-13206
    Event Type
    Injury
    Date Received
    July 13, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).: ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALY. THE INS BATTERY WAS AT NORMAL END OF LIFE AND T ELEMETRY AND OUTPUT WERE OKAY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V858673, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V183416, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) FELT THE BATTERY LASTED A SHORTER TIME AND ITS LONGEVITY WAS IN QUESTION. THE IM PLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO THERAPY IMPEDANCE MEASUREMENTS AS THE CLINICIAN DID NOT HAVE THEM. THE PATIENT'S HISTORY OF REPLACEMENTS WAS AROUND THE TWO YEAR MARK. IT WAS UNDETERMINED IF HIS THERAPY SETTINGS HAD GONE UP OR CHANGED OVER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453930 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention