BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2600040 · Received June 6, 2012

    Report

    Report Number
    3004209178-2012-04052
    Event Type
    Injury
    Date Received
    June 6, 2012
    Report Date
    May 11, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): LEAD MODEL 3998, LOT# V053142, IMPLANTED: 2007-(B)(6), EXPLANTED: NA; EXTENSION MODEL 3708240, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), EXPLANTED: UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S NEUROSTIMULATOR WAS EXPLANTED DUE TO INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL REPORTED THAT THE CULTURES OBTAINED SHOWED NO ANAEROBIC GROWTH BUT WAS A STAPH-TYPE OF INFECTION LOCATED AT THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD SITES. IT WAS NOTED THAT THE DEVICES WERE DISCARDED AT THE HOSPITAL AT THE TIME OF EXPLANTATION. THE PATIENT OUTCOME FROM THE INFECTION WAS REPORTED AS "FAVORABLE" AND IT WAS NOTED THAT THE PATIENT HAD BEEN IMPLANTED WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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