BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3092565 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07281
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4) IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POCKET SITE. IT WAS NOTED THAT A MEDICAL INTERVENTION WAS PLANNED TO TAKE PLACE ON (B)(6) 2013. IT WAS NOTED THAT THE DATE OF ONSET WAS UNKNOWN AND NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED. SEVERAL ATTEMPTS TO FOLLOW-UP WITH THE HEALTHCARE PROVIDER FOR ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193895 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Required Intervention