BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4102931 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17409
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 26, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    . ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (B)(4) FOUND NO SIGNIFICANT ANOMALY. THE BATTERY WAS FOUND TO HAVE REDUCED CAPACITY DUE TO OVERDISCHARGE. PRODUCT ANALYSIS SUMMARY :THE INS WAS RECEIVED WITH NO TELEMETRY. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS AFTER PMR RECOVERY, THE TOTAL RECHARGE COUNT IS 33. THE LAST RECORDED RECHARGE SESSION DONE WHILE THE DEVICE WAS IMPLANTED WAS ON (B)(6) 2000. THE DEVICE WAS RECHARGED FOR 2 HOURS AND 50 MINUTES AND THE BATTERY CHARGED FROM 1.980V TO 3.375V. THE PARAMETER TREND DIAGNOSTIC SECTION OF THE TRACE REPORT SHOWS THE LATEST PATIENT USAGE OCCURRED ON (B)(6) 2013. THE BATTERY DISCHARGED TO THE LOCK MODE ON (B)(6) 2013. THE INS WAS RECHARGED FOR ANALYSIS. A NORMAL RECHARGE WAS STARTED MANUALLY AFTER A PHYSICIAN MODE RECHARGE. THE RECHARGER HAD FULL C OUPLING WITH APPROXIMATELY 1CM OF SPACE BETWEEN THE ANTENNA AND THE INS. THE INS RECHARGED FOR 9 HOURS AND 25 MINUTES FROM 2.665V TO 4.005V. (B)(4).

    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 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 7754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, 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 HAD A LOSS OF STIMULATION AND THERAPEUTIC EFFECT IN (B)(6) 2013. THEY WERE GETTING LESS THAN 50% THERAPY RELIEF IN THEIR THORACIC REGION. THEY ALSO EXPERIENCED OVERSTIMULATION AT THAT TIME. ON (B)(6) 2014 IT WAS REPORTED THAT THE STIMULATION WAS NOT WORKING FOR THE PATIENT. THE PATIENT HAD TRIED A FEW ADJUSTMENTS BUT THEY DID NOT RECEIVE ENOUGH PAIN RELIEF. THE PATIENT WAS EXPERIENCING PAIN IN THEIR CHEST WALL. THE PATIENT HAD THEIR DEVICE EXPLANTED ON (B)(6) 2014. THEY HAD IT EXPLANTED BECAUSE IT WAS NOT WORKING AT ALL AND THEY WEREN¿T GETTING ENOUGH RELIEF. THERE WAS NOT NORMAL BATTERY DEPLETION AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584913 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