BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2961439 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02627
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S BATTERY LOCATION WAS GOING TO BE MOVE FROM HIS BACK TO HIS FRONT SIDE. IT WAS INDICATED THAT THIS WAS THE PATIENT'S PREFERENCE. ABOUT THREE MONTHS LATER IT WAS REPORTED THAT THE PATIENT NEEDED SURGERY BECAUSE THE STIMULATOR WAS IN THE 'WRONG' SPOT, NEAR HIS GROIN. IT WAS STATED THAT THIS WAS 'VERY PAINFUL' FOR THE PATIENT. THE PATIENT WAS GOING TO HAVE A REVISION SURGERY, BUT A DATE WAS NOT PROVIDED. THE PATIENT WAS GIVEN AN ORAL MEDICATION PRESCRIPTION, BUT COULD NOT FILL IT BECAUSE HIS INSURANCE DID NOT COVER IT. IF THE PATIENT STILL HAD ISSUES, HE WAS GOING TO FOLLOW UP WITH HIS HEALTH CARE PROVIDER. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65740 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention