BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3926492 · Received July 10, 2014

    Report

    Report Number
    3004209178-2014-12799
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V119981, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V149877, IMPLANTED: (B)(6) 2009; PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HIS DEVICE OR THERAPY. THE PATIENT MET WITH HIS HEALTH CARE PROVIDER (HCP) AND HIS CONCERNS WERE RESOLVED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE WAS SEEN ON THE RIGHT IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT ASKED IF THIS LONGEVITY WAS NORMAL AS HIS FIRST INS¿S LASTED 3.5 YEARS AND THIS LASTED ONLY 2. THE PATIENT INDICATED THAT THE ¿VOLTAGE ON HIS RIGHT INS WAS AT 2.82 BACK IN (B)(6). IT WAS NOW 2.58 AND WHEN IT REACHED 2.6 IT NEEDED TO BE REPLACED. THE PATIENT WAS FRUSTRATED WHY HE WAS GOING THROUGH THESE BATTERIES SO QUICKLY.¿ THE PATIENT NOTED THAT HE WAS VERY ACTIVE AND THE DOCTOR MADE ¿SMALL TWEAKS, BUT NOTHING MAJOR.¿ THE INS WAS ON ¿24/7.¿ THE PATIENT MENTIONED THAT HIS DOCTOR WAS ALSO SURPRISED BY THE SHORT BATTERY LIFE. THE PATIENT REMEMBERED THAT THE MANUFACTURER REPRESENTATIVE TOLD HIM AT THE REPLACEMENT SURGERY THAT ¿THESE WERE THE NEWEST AND GREATEST AND THEY SHOULD LAST LONGER AND THEY WERE BETTER BATTERIES THAN THE OLDER ONES.¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404196 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1