BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2790876 · Received October 15, 2012

    Report

    Report Number
    3004209178-2012-09202
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Report Date
    September 21, 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 Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748966, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 748966, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3986A, LOT# N171052, IMP LANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3986A, LOT# N132039, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 39565-30, 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 THE PATIENT HAD INCREASE IN PAIN. A LONGEVITY CALCULATION WAS PERFORMED TO ESTIMATE THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY LIFE. BASED CALCULATION ON: 5.6V, 330US, 40 HZ, AND 24/7 USE, 240 OHMS. ESTIMATION WAS 10 MONTHS. THE ELECTRODE IMPEDANCES WERE NORMAL RANGE EXCEPT #2 PAIRS WERE ALL > 10K PER CALLER AND BUT THERE WERE NO LOW IMPEDANCES. HOWEVER, THE ELECTRODE #2 WAS NOT USED IN PROGRAMMING. THE PATIENT HAD BEEN SEEN FOR REPROGRAMMING TO IMPROVE COVERAGE DUE TO INCREASE IN PAIN. THE PATIENT HAD 2 DEVICES AND THIS ONE WAS FOR RIGHT ARM COVERAGE AND PER THE LEAD CONFIGURATION, IT APPEARED THEY WERE USING A 565 WITH THIS INS. IT WAS INDICATED THAT THERE WAS NOT MALFUNCTIONS, THE PATIENT HAD GROWING TUMOR ON SPINAL CORD THEREFORE PAIN SPREADING TO OTHER AREAS. THERE WERE NO PLANS FOR INTERVENTION. THE PATIENT REPORTED IMPROVED PAIN LEVEL AFTER REPROGRAMMING (FROM 10 TO 4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1