BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4093349 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17112
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 22, 2014
    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 37744, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS, S/N (B)(4), FOUND THE INS WAS FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS A VERY TINY PATIENT AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PROTRUDING AND HURTING HER. AT THE LOCATION OF THE RIGHT-SIDED IMPLANT, THE PATIENT EXPERIENCED A BURNING SENSATION AND PAIN. IMPEDANCE TESTING WAS PERFORMED AND THE DEVICE WAS EXPLANTED ON (B)(6) 2014 AND REPLACED WITH A NEW DEVICE. AT THE TIME OF THE REPORT, THE PATIENT WAS ALIVE WITH NO INJURY. FOLLOWING THE REPLACEMENT, THE MANUFACTURER¿S REPRESENTATIVE REPORTED THAT IT WAS A SIMPLE BATTERY CHANGE AND IT WAS A MATTER OF THE IMPLANT BEING TOO BIG FOR SUCH A SMALL PATIENT. FOLLOWING REPLACEMENT, THE PATIENT WAS DOING GREAT AND SHE WAS HAPPY WITH HER THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571823 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