BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3242706 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12159
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 1, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS A WRONG PLACEMENT OF LEAD. SYMPTOM ASSOCIATED WITH THE EVENT WAS NO RELIEF. PATIENT HAD NOT REQUIRED HOSPITALIZATION AND THERE WAS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PAIN STIM SYSTEM NEVER WORKED. PATIENT HAD NOT PREVIOUSLY MENTIONED IT BECAUSE SHE WAS TOO NERVOUS TO HAVE A PROCEDURE AGAIN. THE DEVICE WAS EXPLANTED ABOUT A YEAR PRIOR TO THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342744 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention