BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4823922 · Received June 8, 2015

    Report

    Report Number
    3004209178-2015-10373
    Event Type
    Injury
    Date Received
    June 8, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37713, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3888-45, LOT# V053528, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V000790, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-45, LOT# V038166, IMPLANTED: (B)(6)2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V053528, IMPLANTED: (B)(6)2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6)2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT.(B)(4).

    Additional Manufacturer Narrative · 1

    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

    ANALYSIS RESULTS ON THE INS (B)(4) INDICATE THAT THE STIMULATOR BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE. PRODUCT ANALYSIS #(B)(4):THE INS WAS RECEIVED WITH NO TELEMETRY. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS AFTER PMR RECOVERY, THE TOTAL RECHARGE COUNT IS (B)(4). THE LAST RECORDED RECHARGE SESSION PERFORMED WHILE THE DEVICE WAS IMPLANTED AND BEFORE POR; OCCURRED ON (B)(6) 2012. THE DEVICE WAS RECHARGED FOR 1 HOUR 29 MINUTES AND THE BATTERY CHARGED FROM 3.830V TO 4.020V. THE BATTERY DISCHARGED TO THE LOCK MODE ON (B)(6) 2012. THE PARAMETER TREND DIAGNOSTIC SECTION OF THE TRACE REPORT SHOWS THE LAST PATIENT USAGE WAS ON (B)(6) 2011.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT TWO STIMULATORS WERE EXPLANTED ON (B)(6) 2015 DUE TO OVERDISCHARGE BECAUSE THE PATIENT HAD NOT CHARGED IN OVER 6 YEARS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NOT CHARGED THEIR DEVICE FOR SIX YEARS; THERE WAS A CONFIRMED OVER DISCHARGE. THE PATIENT WAS SEEN IN THE CLINIC FOR POTENTIAL REPLACEMENT OF THEIR DEVICE. THE MANUFACTURER REPRESENTATIVE (REP) ATTEMPTED TO READ THE IMPLANTABLE NEUROSTIMULATOR (INS) BUT WAS UNABLE TO GET A RESPONSE FROM THE BATTERY. THE PATIENT HAD GOOD PAIN CONTROL WITH ORAL MEDICATIONS FOR THE LAST SIX YEARS. INFORMATION OBTAINED LATER NOTED THAT BOTH OF THE PATIENT¿S BATTERIES WERE OVER DISCHARGED AND REPLACEMENTS HAD NOT BEEN SCHEDULED. THE PATIENT¿S PAIN CONTINUED TO BE MANAGED WITH ORAL MEDICATIONS. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE NOTED. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368013 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention