BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3033522 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04566
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT# V006947, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V006947, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3389S-40, LOT# V006947, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 3389S-40, LOT# V006947, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD 'NOT BEEN ACTING HIMSELF' FOR THE PAST 4 DAYS PRIOR TO THIS REPORT AFTER THE PATIENT FELL TWICE. IT WAS NOTED THAT THE PATIENT WAS 'ILL AND HIS PERSONALITY WAS DIFFERENT.' IT WAS ADDED THAT THE PATIENT WAS 'USUALLY HAPPY AND FRIENDLY AND HE ISN'T RIGHT NOW.' IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS AN INFECTIOUS PROCESS UNRELATED TO THE DEEP BRAIN STIMULATOR (DBS). IT WAS NOTED THAT THE PATIENT FOLLOWED UP WITH THEIR PRIMARY CARE PROVIDER AND WAS NOT HOSPITALIZED FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135796 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1