BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5635736 · Received May 5, 2016

    Report

    Report Number
    3004209178-2016-08965
    Event Type
    Malfunction
    Date Received
    May 5, 2016
    Report Date
    May 5, 2016
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37761 LOT# SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 74001, LOT# N240169, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID: UNKEXT, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT ID: UNKN-LD, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. ANALYSIS DETERMINED THAT THE CONNECTOR WAS BROKEN ON THE DESKTOP CHARGER (S/N (B)(4)).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECHARGER (INSR) WAS NOT CHARGING. THE PIN HAD BROKEN A COUPLE OF WEEKS PRIOR. INDICATION FOR USE INCLUDED RSD CAUSALGIA - COMPLEX REGIONAL PAIN SYNDROME IT WAS FURTHER REPORTED THAT AN OVERDISCHARGE (OD) WAS SUSPECTED. THE PATIENT REITERATED THAT THE RECHARGER WAS NOT CHARGING AND SHE GOT A REPLACEMENT. THE PATIENT THEN HAD TO WAIT FOR AN APPOINTMENT WITH HER PHYSICIAN AND SHE WAS THEN DIRECTED TO CALL THE COMPANY. THE LAST TIME THE PATIENT FELT STIMULATION WAS 2.5 MONTHS AGO, WHICH IS ALSO THE TIME OF THE LAST SUCCESSFUL RECHARGE SESSION. THE PHYSICIAN MODE RECHARGE PROCESS WAS DISCUSSED AND THE PATIENT WAS REDIRECTED TO HER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289589 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR