BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3902361 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12268
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    September 27, 2013
    Report Date
    June 12, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL IN (B)(6) OF 2013 AND IT TORE ONE OF THE LEADS AND DAMAGED THE DEVICE. IT WAS ALSO REPORTED THAT THE AREA GOT INFECTED. THE PATIENT REPORTEDLY HAD THE DEVICE REPLACED IN (B)(6) OF 2013 AND THE BATTERY WAS CHANGED TO A SMALLER IMPLANTABLE NEUROSTIMULATOR (INS) AND THEY CUT OUT A NEW POCKET. IT WAS NOTED THAT THE PATIENT FELT THAT THE LEADS WERE REPLACED AS WELL. THERE WAS REPORTEDLY ONLY ONE INCISION NEAR THE INS WHEN THE REPLACEMENT WAS DONE. 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
    379493 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention