BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2904940 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00384
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 14, 2012
    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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION DEVICE USED FOR WAS MRU. PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 64001, LOT# N293019, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 64001, LOT# N293019, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT# V297034, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V251538, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 64001, SERIAL# UNKNOWN, PRODUCT TYPE: ADAPTOR. SUPPLEMENTAL SUBMITTED TO CORRECT CONCLUSION CODES PATIENT AND DEVICE CODES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS), AS WELL AS EXTENSION, WERE REPLACED BECAUSE THE INS DIDN'T HOLD A CHARGE AND HAD BEEN A PROBLEM FOR THE PATIENT SINCE HE WAS IMPLANTED. THE PATIENT WAS CHARGING HIS DEVICE EVERY OTHER DAY FOR 3 HOURS. IT WAS NOTED THAT THERE WERE 'THERAPY CHANGES' AND A PERIODIC LACK OF THERAPY HAD ALSO DEVELOPED. THE REPORTER INDICATED THAT THE PATIENT HAD POCKET SHOCKS PERIODICALLY BUT IMPEDANCES HAD BEEN FINE. THE PATIENT PROGRAMMER ALSO READ OUT OF REGULATION (OOR) THE WEEK PRIOR TO THE REPLACEMENT. ON THE MORNING OF THE REPORT, THE PATIENT'S BATTERY WAS AT 50% CHARGE AND THE OOR WAS STILL PRESENT. AN ISSUE WITH THE BATTERY WAS SUSPECTED AND THE REPORTER INDICATED THAT THERE MAY HAVE BEEN SOME TROUBLE WITH THE ADAPTOR THAT ALSO CAUSED THE INS REPLACEMENT. THE REPORTER STATED THAT PRIOR TO THE REPLACEMENT, THE PATIENT WAS PROGRAMMED TO 3+,1+,2-. OTHER SETTINGS WERE REPORTEDLY AVERAGE WITH A PULSE WIDTH OF 270'S.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS 'DEFECTIVE.' IF ADDITIONAL INFORMATION IS RE CEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT REPORTER THOUGHT THAT THERE WAS A SHORT IN THE ADAPTOR THOUGH THE IMPEDANCES GOING INTO THE PROCEDURE WAS ¿OKAY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10724 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention