BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 3183151 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10737
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 3, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3550-29 LOT# N331433, IMPLANTED: 2012 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 3 550-39 LOT# N295160, IMPLANTED: 2012 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 3550-14 LOT# N335299, IMPLANTED: 2012 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 355531 LOT# N326917, IMPLANTED: 2012 (B)(6); PRODUCT TYPE SCREENING DEVICE PRODUCT ID 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THE HEALTH CARE PROFESSIONAL OR MANUFACTURER'S RE PRESENTATIVE ON (B)(6) 2013 FOR A BATTERY REPLACEMENT AND DID NOT HAVE CONCERNS WITH THE DEVICE OR THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND SAW A ¿CALL YOUR DOCTOR" ICON ON THEIR PATIENT PROGRAMMER. IT WAS STATED, THE PATIENT SAW AN END OF SERVICE (EOS) SYMBOL ON (B)(6) 2013. IT WAS NOTED, THE PATIENT RAN THEIR DEVICE AT 6, 7 OR 8 VOLTS BUT DID NOT HAVE IT ON ALL OF THE TIME. IT WAS REPORTED, THE PATIENT WAS TOLD BY THEIR DOCTOR THAT THE DEVICE WOULD LAST 10 YEARS AND THEN THEY SAID 5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284003 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention