BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2832097 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10257
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 16, 2012
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL # (B)(4)) FOUND THAT IT WAS OVER DISCHARGED AND PERMANENTLY DAMAGED. THE INS WAS RECEIVED WITH NO TELEMETRY. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS AFTER PMR RECOVERY, THE TOTAL RECHARGE COUNT IS 38. THE LAST RECORDED RECHARGE SESSION DONE WHILE THE DEVICE WAS IMPLANTED WAS ON (B)(6) 2010. THE DEVICE WAS RECHARGED FOR 15 SECONDS. THE BATTERY VOLTAGE REMAINED AT 3.775V. THE RECHARGE PRIOR WAS ON (B)(6) 2010. THE CHARGE LASTED 3 HOURS AND 43 MINUTES AND THE VOLTAGE WENT FROM 3.68V TO 4.030V. THE BATTERY DISCHARGED TO THE LOCK MODE ON (B)(6) 2010. TESTING OF THE RECHARGE FUNCTION OF THIS INS FOUND IT TO BE FUNCTIONING NORMALLY. THE INS WAS RECHARGED AT BODY TEMPERATURE WITH APPROXIMATELY 1CM OF SPACE BETWEEN THE INS AND CHARGER ANTENNA. THE RECHARGER HAD FULL COUPLING AND THE INS RECHARGED FOR 3 HOURS AND 29 MINUTES FROM 2.560V TO 3.545V. THE BATTERY DISCHARGED TO LOCK MODE WITHIN MINUTES OF CHARGE COMPLETION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39565 LOT# SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NO LONGER ABLE TO CHARGE HER BATTERY AND THE NUMBER OF "TRICKLE CHARGE" ATTEMPTS WAS UNKNOWN. IT WAS MARKED AS NOT NORMAL BATTERY DEPLETION AND THAT THE PATIENT WAS "NONCOMPLIANT." THE DEAD BATTERY WAS REPLACED AND THERE WERE "A LOT OF UNKNOWNS." THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Required Intervention