BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3932744 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12983
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 399930, LOT# J0564105V, IMPLANTED: 2005 (B)(6);: PRODUCT TYPE LEAD PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 74002, LOT# N401672, IMPLANTED: 2014 (B)(6); PRODUCT TYPE ADAPTER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING THEIR LEADS REPLACED ON THE DAY OF THE REPORT. SOMEHOW DURING THE LEAD REPLACEMENT, THE DOCTORS DAMAGED THE BATTERY AND THE BATTERY WAS REPLACED. POST-OP, THE PATIENT LIKED THEIR DEVICE AND HAD GOOD COVERAGE. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WOULD NOT BE RETURNED. THE MANUFACTURER REPRESENTATIVE WAS NOT SURE WHAT THEY DID TO DAMAGE THE INS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409829 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR