BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3555370 · Received January 6, 2014

    Report

    Report Number
    3004209178-2014-00226
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 10, 2013
    Report Date
    December 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3776-45, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3550-29, LOT# N202807, IMPLANTED: 2010 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 3550-39, LOT# N243316, IMPLANTED: 2010 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 377660, LOT# V013969, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 377660, LOT# V013969, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS STIMULATION IN THE WRONG LOCATION. THE PATIENT DROVE TO APPOINTMENT SIX DAYS PRIOR TO THE REPORT AND WAS ADJUSTED. WHEN HE GOT HOME, THE STIMULATION WAS IN THE WRONG LEG. THE STIMULATION SHOULD BE IN HIS RIGHT LEG AND WAS IN THE LEFT LEG. IT WAS STATED "THEY DID RUN BEFORE HE LEFT THE APPOINTMENT." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7814 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR