BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4111391 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17568
    Event Type
    Injury
    Date Received
    September 23, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97792, LOT# N358102, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE STIMULATOR REVEALED NO SIGNIFICANT ANOMALIES. THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE. THE INS WAS RECEIVED WITH NO TELEMETRY. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS AFTER PMR RECOVERY, THE TOTAL RECHARGE COUNT WAS 8. THE LAST RECORDED RECHARGE SESSION PERFORMED WHILE THE DEVICE WAS IMPLANTED OCCURRED ON (B)(6) 2013. THE DEVICE RECHARGED FOR 1 HOUR AND 43 MINUTES AND THE BATTERY CHARGED FROM 3.455V TO 3.775V. THE PARAMETER TREND DIAGNOSTIC SECTION OF THE TRACE REPORT SHOWS PATIENT USAGE AFTER THIS RECHARGE SESSION. THE BATTERY DISCHARGED TO THE LOCK MODE ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT WAS HAVING STIMULATION/THERAPY ISSUES. STIMULATION NEVER WORKED FOR THE PATIENT. THE PATIENT WAS TOLD TO TURN STIMULATION OFF AND TO NOT USE IT AGAIN. THE EXACT ISSUE WAS NOT KNOWN. THE DEVICE WAS EXPLANTED AS A RESULT OF THE EVENT. IT WAS NOTED THAT THE HOSPITAL HAS POSSESSION OF THE DEVICE AND THE IMPLANTABLE NEUROSTIMULATOR(INS) WAS GOING TO BE LOOKED AT BY RISK MANAGEMENT FOR EVALUATION. IT WAS REPORTED THAT THE PATIENT WAS DOING FINE POST EXPLANT. FURTHER FOLLOW-UP IS BEING CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE DEVICE WAS REMOVED DUE TO TENDERNESS, BACK PAIN AND GENERAL IRRITATION OVER THE DEVICE SITE AND A GRADUAL THERAPY CHANGE. THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE. THE STIMULATOR NEVER WORKED FOR THE PATIENT FROM THE START. THEY HAD THE DEVICE ON FOR ABOUT THREE MONTHS AND THEN THEY HAD IT OFF FOR THE LAST YEAR. WHEN THE STIMULATOR WAS ON IT SENT JOLTS OF ELECTRICITY THROUGH THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589931 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