BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2990224 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03337
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    November 28, 2012
    Report Date
    February 22, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3888, LOT# L49632, IMPLANTED: (B)(6) 1998, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIS INS REPLACED WITH A NEW INS AND A POCKET ADAPTOR AND FOLLOWING THE REPLACEMENT HAD NO STIMULATION SENSATION. IT WAS NOTED THAT THE PATIENT HAD STIMULATION SENSATION PRIOR TO HIS PREVIOUS INS DEPLETING. IMPEDANCES WERE WITHIN NORMAL RANGE, BUT REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE AND THE HCP DECIDED TO TRY TAKE AN X-RAY OF THE LEAD SITE AT THE PATIENT'S FOLLOW-UP VISIT. REPROGRAMMING WAS ATTEMPTED WITHOUT SUCCESS AT THE FOLLOW-UP APPOINTMENT, AND THE PATIENT WAS UNABLE TO FEEL STIMULATION EVENT AT 10 .5 VOLTS. IMPEDANCES WERE WITHIN NORMAL RANGE. IT WAS LATER REPORTED THAT IMPEDANCES WERE ABOVE 10,000 OHMS ON EACH CONTACT, AND THE HCP WAS PLANNING ON REPLACING THE LEADS. IT WAS UNKNOWN IF THE OPERATION HAD BEEN PERFORMED, AND IT WAS NOT CLEAR WHAT HCP THE PATIENT WAS SEEING. 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
    93680 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention