BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2579802 · Received May 18, 2012

    Report

    Report Number
    3004209178-2012-03463
    Event Type
    Injury
    Date Received
    May 18, 2012
    Report Date
    April 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# V101646, IMPLANTED: 2008-(B)(6), (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID (B)(4), LOT#, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED, PRODUCT TYPE: EXTENSION, PRODUCT ID (B)(4), LOT#, SERIAL# (B)(4), IMPLANTED, EXPLANTED, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID (B)(4), LOT#, SERIAL# (B)(4), IMPLANTED, EXPLANTED, PRODUCT TYPE: PROGRAMMER, PATIENT PRODUCT ID (B)(4), LOT# V101646, SERIAL#, IMPLANTED: 2008 (B)(6), EXPLANTED: PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HOSPITALIZED AND WAS "SEVERELY CATATONIC," WHICH WAS "RELATED TO A LACK OF THERAPY." IT WAS ALSO REPORTED THERE WERE HIGH IMPEDANCE READINGS OF >40,000 OHMS ON ELECTRODE # 2. THERAPY IMPEDANCES WERE WITHIN NORMAL RANGE. IT WAS NOTED THE PATIENT HAD A BATTERY REPLACEMENT PROCEDURE ON (B)(6) 2012, AND NO COMPLICATIONS OR IRREGULARITIES WERE SEEN. THE PATIENT DID NOT REPORT ANY FALLS OR TRAUMA IN THE INTERIM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A LEAD FAILURE IN THE NEWLY IMPLANTED DEVICE OCCURRED IN (B)(6). IT WAS STATED THAT THE PATIENT WAS REPROGRAMMED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization