BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2950248 · Received February 8, 2013

    Report

    Report Number
    3004209178-2013-01475
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 21, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 389056, LOT# J0537566V, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 389056, LOT# V006542, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 377675, LOT# V008370, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: RECHARGER: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A 3RD OVER DISCHARGE EVENT. THE PROGRAMMER WAS DISPLAYING THE "END OF SERVICE" OR "END OF LIFE" MESSAGE. A REPLACEMENT SURGERY WAS PLANNED FOR (B)(6) 2013. THEY WERE GOING TO REPLACE THE BATTERY WITH A NON-RECHARGEABLE ONE SINCE THE PATIENT HAD COMPLIANCE ISSUES WITH RECHARGING. NO FURTHER INFORMATION WAS PROVIDED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED, THE PATIENT WAS DOING FINE. IT WAS LATER REPORTED, THE PATIENT HAD A CHARGE ISSUE WHICH CAUSED THE LEAD TO NOT STIMULATE THEM WHERE THEY NEEDED. IT WAS NOTED THERE WAS A LOSS OF THERAPEUTIC EFFECT PRIOR TO REPLACEMENT OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54486 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention