BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4202856 · Received October 27, 2014

    Report

    Report Number
    3004209178-2014-20411
    Event Type
    Injury
    Date Received
    October 27, 2014
    Report Date
    October 7, 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 Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-39, LOT# N213355, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3778-4, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCES (>10,000 OHMS) WERE REPORTED ON ONE OF THE LEAD COMPONENTS OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS). IN ADDITION TO IMPEDANCE TESTING, REPROGRAMMING WAS PERFORMED AS DIAGNOSTIC/TROUBLESHOOTING ACTIONS. THE CAUSE OF THE HIGH IMPEDANCE WAS UNKNOWN. IT WAS NOTED THAT THE PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF TO THEIR LOW BACK AND LEGS. THE PATIENT WAS SCHEDULED FOR A PROCEDURE TO REPLACE BOTH LEADS (ONE WITH HIGH IMPEDANCES) AND THE INS WHICH WAS DUE FOR REPLACEMENT. THE PATIENT WAS REPROGRAMMED IN RECOVERY WHERE FULL COVERAGE WAS OBTAINED. NO OTHER DETAILS OR AN OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681316 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