BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5075126 · Received September 14, 2015

    Report

    Report Number
    3004209178-2015-17904
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    November 1, 2014
    Report Date
    August 20, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V113842, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V106048, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL VIA THE MANUFACTURING REPRESENTATIVE REPORTED THAT THERE WAS A POSSIBLE/SUSPECTED OVERDISCHARGE. THE PATIENT HAD POTENTIALLY NOT CHARGED THEIR RECHARGEABLE DEVICE SINCE NOVEMBER 2014. A HEALTHCARE PROFESSIONAL INQUIRED IF THE DEVICE COULD BE RECOVERED. NO PATIENT SYMPTOMS WERE REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN INFORMATION ABOUT THE ISSUE, CAUSE, TROUBLESHOOTING, ACTIONS TAKEN AND OUTCOME. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD NOT BEEN SEEN AT THEIR OFFICE SINCE (B)(6) 2012. IT HAD APPEARED THAT NEITHER THE PATIENT OR CAREGIVERS HAD PAID ATTENTION TO STIMULATORS OR RECHARGERS AND NO ONE HAD TAKEN THE RESPONSIBILITY TO MAKE SURE THAT HER BATTERY WAS RECHARGED. IT WAS UNKNOWN WHEN THE BATTERY WAS LAST CHARGED. IT WAS UNKNOWN WHAT FURTHER ACTION HAD BEEN TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606357 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR