BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3180766 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10665
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3550-P4 LOT# N266669, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID: 3 7744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) BATTERY DEPLETED PREMATURELY. IT WAS NOTED THAT A REPLACEMENT WAS PLANNED BUT NOT YET SCHEDULED. THE REPORTER STATED THAT THERE WAS NO PATIENT INJURY RELATED TO THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR REPLACEMENT ON (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR REPLACEMENT WAS DUE TO ¿NORMAL DEPLETION.¿

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT DID HAVE A REVISION OF THE LEAD COMPONENT AT WHICH TIME IT WAS MOVED A LITTLE MORE MIDLINE TO CAPTURE MORE OF THEIR RIGHT SIDE (NOTHING WAS REPLACED). THE PATIENT WAS REPORTED AS NOW GETTING GOOD COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280934 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention