BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3082612 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07011
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    September 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS REVEALS NO ANOMALY FOUND. NORMAL DEVICE FUNCTION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 64002, LOT# N306619, EXPLANTED: (B)(6) 2013, PRODUCT TYPE ADAPTER; PRODUCT ID 3550-29, LOT# UNKNOWN, EXPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387-40 LOT# J0455264V, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 748240 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3387-40 LOT# J0455264V, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 748240 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 64002 LOT# N306619, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ADAPTER. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    FURTHER FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S SETTINGS ON THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WERE FOR GROUP A: (L) 2.3 VOLTS, C+, 0-, 150 PULSE WIDTH, 250 HZ; (R) 1.8 VOLTS, C+, 5-, 150 PULSE WIDTH, 250 HZ. GROUP B WAS NOTED AS: (L) 2.8 VOLTS, 1+, 0-, 150 PULSE WIDTH, 250 HZ; (R) 3.4 VOLTS, 6+, 5-, 180 PULSE WIDTH, 250 HZ. THE THERAPY IMPEDANCE VALUES WERE REPORTED AS LEFT = 736 OHMS, RIGHT = 992 OHMS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SAW AN ELECTIVE-REPLACEMENT-INDICATOR (ERI) MESSAGE ON THE PATIENT PROGRAMMER. IT WAS NOTED THAT THE PATIENT HAD BEEN AT THE HCP OFFICE TWO AND A HALF WEEKS AGO AND THE HCP HAD STATED THAT THE BATTERY WAS FINE. THE PATIENT WONDERED IF THE INS WAS DRAINING ABNORMALLY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION. IT WAS STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) ONLY LASTED 8 MONTHS. ALL IMPEDANCES WERE REPORTED TO BE BETWEEN 750 AND 1800 OHMS, THE THERAPY IMPEDANCE WAS UNKNOWN. ESTIMATED LONGEVITY CALCULATIONS WERE USED WITH BOTH GROUPS THE PATIENT HAD. IT WAS UNKNOWN WHICH GROUP WAS USED MORE OFTEN (GROUP 1: L: 3.4V, 180US, 250HZ, 6+, 5-, 1250 OHMS; R: 2.8V, 150US, 250 HZ, 1+, 0-, 1250 OHMS, ERI 16 MONTHS, EOS 18.5 MONTHS) (GROUP 2:L: 1.8V, 150US, 250HZ, C+, 0-, 1250 OHMS; R: 2.3V, 150US, 250 HZ, C+, 5-, 1250 OHMS, ERI 2.8 YEARS, EOS 3 YEARS). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS REPLACED AND THE PATIENT SEEMED TO BE DOING FINE WITH THE THERAPY. IT WAS NOTED THE HEALTH CARE PROVIDER WAS CURIOUS WHY IT DEPLETED SO QUICKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185668 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention