BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3446819 · Received November 4, 2013

    Report

    Report Number
    3004209178-2013-20143
    Event Type
    Injury
    Date Received
    November 4, 2013
    Report Date
    May 5, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3389S-40, LOT# V230720, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    INTERVENTION REQUIRED NO LONGER APPLIED DUE TO NORMAL BATTERY DEPLETION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389S-40, LOT# V230720, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NEARING END OF SERVICE. IT WAS NOTED THAT THE PATIENT¿S SETTING HAD A HIGH CURRENT. THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. THE BATTERY DEPLETION WAS NORMAL. THE PATIENT HAD A REPLACEMENT ON (B)(6) 2013. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) ON LASTED FOR 16 MONTHS. IT WAS NOTED THE PATIENT WAS HAVING A REPLACEMENT SURGERY TOMORROW. THE REPORTER STATED THEY WANTED TO MAKE SURE THEY GET A RECHARGEABLE INS. IT WAS NOTED THAT THIS WAS THE PATIENT¿S FOURTH INS ON THEIR RIGHT SIDE. IT WAS FURTHER NOTED THE INS ON THE PATIENT¿S LEFT SIDE WAS WORKING BEAUTIFULLY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566049 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention