BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4409286 · Received January 12, 2015

    Report

    Report Number
    3004209178-2015-00536
    Event Type
    Injury
    Date Received
    January 12, 2015
    Report Date
    December 20, 2014
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 74001, LOT# N213635, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3487A-33, LOT# J0511358V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) FAILED ABOUT A YEAR AFTER IT WAS IMPLANTED. THE ISSUE WAS NOT WITH THE BATTERY, BUT WAS AN ISSUE WITH THE SIGNAL NOT GETTING THROUGH TO THE SPINE. THEY DIDN¿T KNOW WHAT THE ISSUE WAS AND WERE UNABLE TO PERFORM AN MRI TO DIAGNOSE THE ISSUE. THE WHOLE SYSTEM WAS EXPLANTED DUE TO THE ISSUE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25628 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention