BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3120686 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07922
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO CORRECT CONCLUSION CODE. UPON FURTHER REVIEW, CONCLUSION CODE WAS DELETED FROM FILE TO MORE ACCURATELY REFLECT THE PREVIOUSLY REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708140, SERIAL# (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708140, SERIAL# (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 3777-60, SERIAL# (B)(4), PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION ON HER LEFT SIDE, ¿THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD AN INFECTION ALL AROUND IT.¿ THE DEVICE WAS REMOVED ON (B)(6) 2012. IT WAS NOTED THE INS WAS NOT GOING TO BE REPLACED UNTIL JUNE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222309 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