BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2897709 · Received January 4, 2013

    Report

    Report Number
    3004209178-2013-00182
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 12, 2012
    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

    PRODUCT ID, 377845 LOT# V011102, IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 377845 LOT# V010933, IMPLANTED:2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377845, LOT# V011102, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 377845, LOT# V010933, PRODUCT TYPE LEAD, PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S LEADS HAD "FAILED" AND THE PATIENT "HAD THEM PLACED" ON THE DAY OF REPORT. IT WAS NOT CLEAR IF "HAD THEM PLACED" MEANT THE PATIENT HAD A SURGICAL REPLACEMENT OR IF THEY WERE JUST REPROGRAMMED. IT WAS STATED THAT "A GOOD CIRCUIT" WAS RE-ESTABLISHED ALL THE WAY DOWN TO THE PATIENT'S FEET. IT WAS NOTED THAT THE PATIENT HAD NOT USED THE STIMULATOR FOR "OVER A YEAR" AND HAD MISPLACED HER PROGRAMMER. FURTHER INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEADS WERE REPLACED DUE TO "ABNORMAL" IMPEDANCES. PRIOR TO LEAD REVISION, IT WAS STATED THAT THE PATIENT HAD THEIR DEVICE REPROGRAMMED BUT THEY WERE "UNABLE TO CAPTURE COVERAGE" DUE TO HIGH IMPEDANCES, GREATER THAN 20,000 OHMS. FOLLOWING LEAD REVISION, IT WAS REPORTED THAT THEY WERE "ABLE TO CAPTURE COVERAGE IN REPORTED PAINFUL AREA." PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5381 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