BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3851856 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10209
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    May 17, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT¿S STIMULATION STOPPED ON THEIR DEVICE AND THEY HAD TO GET IT REPLACED DUE TO EARLY BATTERY DEPLETION. IT WAS REPORTED THAT THE PATIENT¿S STIMULATOR STOPPED FUNCTIONING ABOUT 1 MONTH PRIOR TO THE REPORT AND THE DEVICE ONLY LASTED 1 YEAR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED ASSISTANCE ON (B)(6) 2014 FROM THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT STILL HAS CONCERNS WITH THEIR DEVICE AND IS MEETING WITH THEIR MANUFACTURER REPRESENTATIVE OR HCP ON (B)(6) 2014. IT WAS REPORTED THE PATIENT'S SECOND DEVICE WAS PLACED ON (B)(6) 2014 AND HAS "RATHER QUICKLY STOPPED FUNCTIONING". IT WAS NOTED THAT CHARGING WAS CONFUSING AND DUE TO THE PATIENT'S HCP BEING ON VACATION THEY HAVE BEEN IN SEVERE PAIN FOR TWO WEEKS. IT WAS NOTED THE PATIENT HAS AN APPOINTMENT SCHEDULED FOR (B)(6) 2014. INFORMATION OMITTED PERTAINING EVENT (B)(4) - INS STOPPED WORKING. THESE EVENTS ARE NOT RELATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD HER PREVIOUS IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED ON (B)(6) 2014. THE PATIENT WAS IN SO MUCH PAIN THAT IT USED THE BATTERY LIFE, SO THEY IMPLANTED HER WITH A STRONGER ONE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329176 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