BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3122051 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07965
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    May 2, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT# V605573, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V603774, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN SHOCKED TWICE AT THEIR DEVICE POCKET SITE AND HAD ONE EPISODE OF HEATING IN THE POCKET. IT WAS ALSO REPORTED THE PATIENT HAD HEARD A BEEP COME FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THE PATIENT HAD NO LOSS OF THERAPY. IT WAS LATER REPORTED THE PRINTOUT OF THE PATIENT¿S FILE SHOWED THERE WERE NO OUT OF REGULATIONS (OORS) REPORTED AND THE BATTERY VOLTAGE DIAGNOSTIC WAS WITHIN SPECIFICATIONS. IT WAS ALSO REPORTED THE IMPEDANCES WERE WITHIN NORMAL RANGE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER STATED THE CAUSE OF THE EVENT WAS UNKNOWN AND THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. IT WAS STATED THE EVENT WAS AN ISOLATED EVENT AND THEY WERE UNABLE TO DETERMINE THE SOURCE OR CAUSE. THE HEALTHCARE PROVIDER REPORTED IT AS A RARE EVENT OF HEAT SENSATION AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET. REPORTEDLY, THEY COULD NOT REPRODUCE THE SENSATION. IT WAS NOTED THERE WAS NO PROGRAMMING ISSUE AND THE PATIENT WOULD KEEP A LOG OF ANY FUTURE SENSATIONS THAT OCCUR IN THE DEVICE POCKET. IT WAS STATED THERE WAS NO INTERRUPTION OR LOSS OF THERAPY REPORTED AND THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THE PATIENT¿S OUTCOME WAS REPORTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224281 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1