BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4555109 · Received February 27, 2015

    Report

    Report Number
    3004209178-2015-03854
    Event Type
    Malfunction
    Date Received
    February 27, 2015
    Date of Event
    February 3, 2015
    Report Date
    February 5, 2015
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 389056, LOT# V005509, IMPLANTED: (B)(6) 2006-06-30 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID: 389056 LOT# V005509 SERIAL# (B)(6) IMPLANTED: 2006-06-30 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID: 355029 LOT# N0042726, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37713, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A ¿CALL YOUR DOCTOR¿ ICON AND AN ELECTIVE REPLACEMENT INDICATOR (ERI) OBSERVED. THE CALLER ALSO INDICATED THAT HE HAD NOT FELT MUCH STIM IN THE PAST TWO DAYS. THE CALLER CHARGED TO FULL THE MORNING OF REPORT. WHILE ON THE CALL, THE CALLER STATED THAT HE FELT STIM AGAIN. ADDITIONAL INFORMATION WAS REQUESTED. IF IT IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138191 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR