BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3013460 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-04003
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 1, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE DEVICE, MODEL # 37711, SN (B)(4), FOUND THE DEVICE TO BE PERMANENTLY DAMAGED DUE TO OVERDISCHARGE. IT WAS STATED THAT INS WAS RECEIVED WITH NO TELEMETRY. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS AFTER PMR RECOVERY, THE TOTAL RECHARGE COUNT IS 45. THE LAST RECORDED RECHARGE SESSION DATE DUE TO OVER DISCHARGE WAS (B)(6) 2000. THE DEVICE WAS RECHARGED FOR 16 MINUTES. THE PARAMETER TREND DIAGNOSTIC SECTION OF THE TRACE REPORT SHOWS THE LAST PATIENT USAGE ON (B)(6) 2008. THE THERAPY AVAIL DIAGNOSTIC SHOWS THE BATTERY HAS DISCHARGED TO THE LOCK MODE 16 TIMES SINCE THE LAST CLINICIAN PROGRAMMER INTERROGATION. BATTERY DISCHARGES RAPIDLY. A NORMAL RECHARGE STARTED AUTOMATICALLY AFTER 4 PHYSICIAN MODE RECHARGES AT BODY TEMPERATURE WITH A 1CM SPACER BETWEEN THE INS AND RECHARGE ANTENNA. THE RECHARGER HAD FULL COUPLING AND THE INS RECHARGED FOR 57 MINUTES FROM 2.205V TO 3.4V; THE IR AND TRACE REPORT WERE RECORDED. DUE TO RAPID DISCHARGE CHARGING RESUMED FOR 17 HOURS AND 39 MINUTES BRINGING THE BATTERY VOLTAGE FROM 2 .320V TO 3.920V. THE COUPLING RECORD OF THE LAST 4 PATIENT RECHARGE SESSIONS HAS 2 AT 100% AND 1 AT 62.5%, AND 1 AT 50%.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT DIAGNOSTICS COULD NOT BE PERFORMED DUE TO THE DEVICE BATTERY BEING DEAD. IT WAS NOTED THAT NO MALFUNCTIONS WERE SEEN. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE IMPLANTABLE NEUROSTIMULATOR WAS EXPLANTED AND REPLACED ON THE DAY OF THE REPORT. THE BATTERY DIED BEFORE ITS END OF LIFE. ABNORMAL BATTERY DEPLETION WAS STATED. THERE WAS NO PATIENT DEATH OR INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT CHARGE THEIR BATTERY. THE MANUFACTURER REPRESENTATIVE WAS ALSO UNABLE TO RECHARGE IT AND COULD NOT READ THE BATTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A BATTERY REVISION ON THE DAY OF THE REPORT DUE TO RECHARGING ISSUES. IT WAS UNKNOWN IF A PHYSICIAN RECHARGE MODE (PRM) HAD BEEN PERFORMED OR IF THE RECHARGER WAS FUNCTIONING PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116643 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