BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3209140 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-11426
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 14, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF EXTENSION MODEL 748251 SERIAL (B)(4) SHOWED A BREACHED DEPRESSION ON THE OUTER INSULATION 4 CM AND 15.5 CM FROM THE PROXIMAL END. THE CONTINUITY WAS ACCEPTABLE AND NO SHORTS WERE SEEN BETWEEN THE CIRCUITS. THE SET SCREWS MARKED WERE NOTED TO BE IN THE CORRECT LOCATION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 37602, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT # V001236, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT;, PRODUCT ID 3387-40, LOT # V000623, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS SCHEDULED FOR EXTENSION REPLACEMENT. IT WAS NOTED THAT ABOUT 1 CM OF INSULATION WAS MISSING FROM THE DUCKBILL OF THE EXTENSION. AN ATTEMPT WAS MADE TO REPROGRAM AROUND IT BUT WAS UNSUCCESSFUL. IT WAS STATED THE PATIENT COULD NOT TOLERATE PREVIOUS SETTINGS WHICH WERE LOWERED TO 2.7 VOLTS AND ¿CONTACT -3¿ WAS REMOVED. IT WAS NOTED THE PATIENT FELT GOOD THERAPY. IT WAS NOTED DURING AN INS REPLACEMENT ON (B)(6) 2013, IT WAS NOTED A PORTION OF THE EXTENSION INSULATION WAS MISSING APPROXIMATELY 1 CENTIMETER BELOW THE TWO PRONG CONNECTOR. THERAPY IMPEDANCE REMAINED VERY LOW IN THE 400 RANGE. IT WAS STATED ON (B)(6) 2013, REPROGRAMMING WAS ATTEMPTED BUT THE PATIENT DIDN'T SUSTAIN A THERAPEUTIC BENEFIT. THE PATIENT HAD A SUCCESSFUL EXTENSION REPLACEMENT ON (B)(6) 2013, HOWEVER, IMPEDANCES ¿WERE 1702 <(>&<)> 1.589 MA AND THE VOLTAGE WAS LOWERED TO 2.7 AS SHE COULDN¿T TOLERATE AT THE PREVIOUS 3.5 SETTINGS.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CONFIRMED THAT SOME OF THE INSULATION ON THE EXTENSION APPEARED TO BE MISSING POSSIBLY DUE TO IT RUBBING AGAINST THE INS. THERE WERE NO INJURIES TO THE PATIENT WITH THE OUTCOME REPORTED AS RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309248 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention