BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4308427 · Received December 9, 2014

    Report

    Report Number
    3004209178-2014-22821
    Event Type
    Injury
    Date Received
    December 9, 2014
    Report Date
    November 17, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS (S/N (B)(4)), FOUND NO SIGNIFICANT ANOMALY. THE INS BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE. ANALYSIS OF THE LEADS (L/N V020880 AND V022293), FOUND THE LEAD BODIES HAD BROKEN CONDUCTORS. THE INS WAS RECEIVED WITH NO TELEMETRY. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS AFTER PMR RECOVERY, THE TOTAL RECHARGE COUNT WAS 60. THE LAST RECORDED RECHARGE SESSION PERFORMED WHILE THE DEVICE WAS IMPLANTED OCCURRED ON (B)(6) 2014. THE DEVICE WAS RECHARGED FOR 1 HOUR 54 MINUTES AND THE BATTERY CHARGED FROM 3.445V TO 3.780V. THE PARAMETER TREND DIAGNOSTIC SECTION OF THE TRACE REPORT SHOWED THE LAST PATIENT USAGE WAS ON (B)(6) 2014. THE MOST RECENT DATE THE BATTERY DISCHARGED TO THE LOCK MODE WAS ON (B)(6) 2014; THE TOTAL THERAPY LOSS COUNT WAS 8.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 377860, LOT# V020880, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3887-45, LOT# V022293, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-39, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERAPY LOST EFFECTIVENESS. THE DEVICE WORKED FINE WITH NO DEVICE ISSUES BUT THE PATIENT JUST DID NOT GET ENOUGH RELIEF. THE PATIENT WAS PROGRAMMED BUT IT WAS UNKNOWN WHO DID THE PROGRAMMING OR WHEN IT OCCURRED. THE DEVICE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR ANALYSIS. IT WAS NOTED THAT THERE WAS NO NEW IMPLANT. IT WAS UNKNOWN IF THERE WAS NORMAL BATTERY DEPLETION. THERE WAS NO PATIENT INJURY AND HE RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794375 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention