BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2040751 · Received March 22, 2011

    Report

    Report Number
    3004209178-2011-02182
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 28, 2011
    Report Date
    December 5, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF LEAD MODEL 377860 LOT # V346992006 DETERMINED THE CONDUCTOR WAS BROKEN AT THE ANCHOR SITE. ANALYSIS OF LEAD MODEL 377860 LOT # V387946013 DETERMINED THE CONDUCTOR WAS BROKEN AT OR NEAR THE ANCHOR SITE.

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3778 LOT# V346992006 IMPLANTED: (B)(6) 2010 EXPLANTED: (B)(6) 2011 LEAD MODEL 3778 LOT# V387946013 IMPLANTED: (B)(6) 2010 EXPLANTED: (B)(6) 2011. 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

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD 1 OR 2 CT SCANS WITH MULTIPLE TESTS FOR DIVERTICULITIS. THE PATIENT WAS SEEN ON (B)(6) 2011 WITH A COMPLAINT OF STIMULATION CUTTING IN AND OUT. THE STIMULATION WAS ALWAYS STRONGER IN THE RIGHT LOWER EXTREMITY VERSUS THE LEFT LOWER EXTREMITY. PROGRAMMING SHOWED PROGRESSING IMPEDANCES SINCE THE LAST VISIT, AND ELECTRODES 8-15 YIELDED NO STIMULATION. THE PATIENT WAS SCHEDULED FOR A REVISION, AND BOTH LEADS WERE REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011 THE PT AWOKE WITH LEGS HURTING REAL BAD. THE PT GOT UP TO WALK AND STRETCH AND REALIZED SHE DID NOT HAVE ANY STIMULATION. THE PT CHANGED THE BATTERIES IN THE PT PROGRAMMER, BUT IT SHOWED THE SYSTEM WAS ON BUT STILL NOT WORKING. THE PT RECHARGED THE SYSTEM, CHARGING AND BARS APPROPRIATE, BUT STILL COULD NOT FEEL STIMULATION. THE PT WAS SEEN (B)(6) 2011 AND THE SYSTEM WAS INTERROGATED. AMPLITUDE WAS INCREASED WITHOUT STIMULATION. ELECTRODE IMPEDANCE AT 3AMPS SHOWED >40,000 WITH ELECTRODES 1, 2, AND 12. ELECTRODE 1 AND 2 WERE BEING USED WITH PRIMARY PROGRAMMING IN A GUARDED CATHODE ARRAY. ELECTRODE 12 WAS ALSO USED, BUT UNABLE TO GET ANY PARESTHESIA WITH 8-15 ELECTRODES. THE DEVICE WAS REPROGRAMMED LOWER ON THE LEAD WITH EXCELLENT PARESTHESIA TO BILATERAL LOWER EXTREMITIES AND FEET. THE PT WAS HAPPY WITH THE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention LEAD: MODEL 3778, LOT# V387946013| IMPLANTED:| LEAD: MODEL 3778, LOT# V346992006| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA136162N| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE141732N