BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 4768523 · Received May 13, 2015

    Report

    Report Number
    3004209178-2015-09019
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Report Date
    April 21, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377860, LOT# V020591, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 377860, LOT# V014698, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WANTED TO KNOW IF A LUMBAR SACRAL REPAIR COULD SURGICALLY BE DONE ON A PATIENT WITH STIMULATOR. THE PATIENT HAD BULGING DISCS, WITH RADICULOPATHY BACK PAIN RADIATING DOWN RIGHT LEG. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT NEEDED TO HAVE A BATTERY CHANGE AND BACK SURGERY. THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR DOCTOR OR MANUFACTURER¿S REPRESENTATIVE (REP). AN APPOINTMENT WAS SCHEDULED TO MEET THE PHYSICIAN FROM THE DEPARTMENT OF NEUROSURGERY AND ALSO A REP. ON (B)(6) 2015. IT WAS NOTED THAT THE LAST TIME THE PATIENT MET WITH THE REP., IMPLANTABLE NEUROSTIMULATOR (INS) LONGEVITY CALCULATIONS WERE PERFORMED AND THE REP. TOLD HER THAT THE BATTERY WAS GETTING LOW AND IT WOULD EVENTUALLY NEED TO BE REPLACED. THE PATIENT CONFIRMED SHE HAD A NON-RECHARGEABLE DEVICE THAT WAS IMPLANTED IN 2007. THE PATIENT HAD NOT SEEN THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE YET ON THE PATIENT PROGRAMMER (PP). IT WAS FURTHER NOTED THAT THE PATIENT¿S BACK ISSUE WAND BULGING DISC ISSUES WERE NOT AT ALL RELATED TO THEIR DEVICE. THESE ISSUES HAD PROGRESSED OVERTIME AND SHE WAS NOW SEEKING INTERVENTIONS FOR THESE ISSUES. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2015 INDICATING THAT THE BATTERY DEPLETION DI D NOT REACH ELECTIVE REPLACEMENT INDICATOR OR END OF SERVICE. THE PATIENT HAD THEIR SETTINGS IN CONTINUOUS MODE. THE IMPEDANCES ON ELECTRODE CONTACTS 8-15 WERE GREATER THAN 10,000. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312933 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1