BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3033076 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04545
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 19, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3998 LOT# V022880, IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3708240 LOT# SERIAL# (B)(4) IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. CONTACTS 1 AND 4 HAD HIGH IMPEDANCES. THE PATIENT EXPERIENCED A LOSS OF EFFICACY, AND IT WAS REPORTED THAT THE INS, LEAD AND EXTENSION WERE EXPLANTED. THE PATIENT REQUIRED HOSPITALIZATION DUE TO THE EVENT, AND IT WAS REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SYSTEM WORKED WELL FOR THREE YEARS, AND THEN ALL OF A SUDDEN SHE EXPERIENCED PAIN HER RIGHT LUMBAR AREA AGAIN. THE HCP TURNED STIMULATION UP VERY HIGH TO SEE IF IT WAS WORKING, AND IT WAS REPORTED THAT THE PATIENT ALMOST FLEW ACROSS THE ROOM. THE HCP STATED THAT THE LEADS HAD MOVED AND NO LONGER HAD CONTACT AT THE PROPER POINT. THE PATIENT'S SYSTEM WAS EXPLANTED AND SHE DECIDED TO GET A PUMP IMPLANTED INSTEAD OF REPLACING THE STIMULATOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136307 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R