BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2689230 · Received August 9, 2012

    Report

    Report Number
    3004209178-2012-06687
    Event Type
    Injury
    Date Received
    August 9, 2012
    Report Date
    July 11, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF BOTH LEAD EXTENSIONS FOUND NO SIGNIFICANT ANOMALY- EXTENSION/BODY/CUT THROUGH, PRODUCT SEGMENTED. ANALYSIS OF THE LEAD FOUND NO SIGNIFICANT ANOMALY - STIM LEAD/BODY/CUT THROUGH, PRODUCT SEGMENTED.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# V023517, SERIAL#, IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID 37752, LOT#, SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER; PRODUCT ID 37743, LOT#, SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708360, LOT#, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION; PRODUCT ID 3708360, LOT#, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A DEAD BATTERY, BUT WAS RECHARGING EVERY THURSDAY. APPROXIMATELY A WEEK LATER IT WAS REPORTED THE PATIENT HAD A SUDDEN LOSS OF STIMULATION SENSATION WHILE THE PATIENT WAS WALKING. THE PATIENT HAD USED THE DEVICE 24/7 WITH SETTINGS BETWEEN 5-7 VOLTS. NO STIMULATION SENSATION WAS FELT EVEN WITH INCREASED AMPLITUDE. STIMULATION WAS INCREASED TO 10.5 V AND THE PATIENT COULD FEEL TINGLING ABOUT THE SIZE OF A DIME IN THE AREA OF LEAD PLACEMENT, VERTEBRAL BODY T9. AN IMPEDANCE CHECK FOUND NORMAL IMPEDANCES, 800-1,000 OHMS. AN X-RAY WAS PERFORMED AND IT WAS STATED IT WAS FINE. IT WAS UNKNOWN IF IT WAS A LATERAL X-RAY. APPROXIMATELY TWO WEEKS LATER IT WAS REPORTED THAT THE PATIENT HAD A LEAD REVISION. UPON DISCONNECTING THE LEAD FROM THE EXTENSION THE PHYSICIAN NOTED THAT THERE WAS "SOME CORROSION" AT THE CONNECTION SITE. THE EXTENSIONS WERE ALSO REPLACED. THREE HOURS POSTOPERATIVELY STIMULATION WAS TESTED AND THE PATIENT HAD GOOD THERAPY. NO PATIENT INJURY WAS NOTED. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention