BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3293355 · Received August 16, 2013

    Report

    Report Number
    3004209178-2013-14740
    Event Type
    Injury
    Date Received
    August 16, 2013
    Report Date
    July 23, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3888-33, LOT # V040902, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT # V020235, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, 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; PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (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

    FINAL DEVICE ANALYSIS FOR INS (B)(4) REVEALED NO SIGNIFICANT ANOMALY. THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RECHARGING TOOK 6 PLUS HOURS AND THE PATIENT WOULD GO FROM ALL BLACK BARS TO NO BLACK BARS IF THEY MOVED A CENTIMETER. IT WAS NOTED THAT THE PATIENT DECLINED A TRICKLE CHARGE PRIOR TO EXPLANT. ACTIONS REQUIRED AS A RESULT OF THE EVENT WERE EXPLANT AND REPLACEMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WOULD BE A REVISION/REPLACEMENT OF SPINAL CORD STIMULATOR LEADS AND GENERATOR. THE REASON FOR THE REVISION WAS THAT THE CURRENT SYSTEM WAS NOT FUNCTIONAL. THE RE-IMPLANTING WAS TO OCCUR IN SEPTEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396620 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 Required Intervention