BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2212636 · Received August 11, 2011

    Report

    Report Number
    3004209178-2011-06267
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 1, 2011
    Report Date
    October 17, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS ON THE IMPLANTABLE NEUROSTIMULATOR (INS) (MODEL NO. 37712, SERIAL NO. (B)(4)) REVEALED THAT THE INS HAD NO VISIBLE ANOMALIES. THE INS WAS RECHARGED FOR ANALYSIS. THERE WAS GOOD STABLE OUTPUT ON EACH ELECTRODE PAIR AT PATIENT'S SETTINGS AS WELL AS EVERY ELECTRODE REFERENCED TO THE #0 ELECTRODE USING THE PATIENT'S LEAD CONFIGURATION (5-6-5). NO ISSUES REPORTED WHEN PRESSING ON THE INS CAN. OUTPUT MEASURED AT THE CUT DISTAL ENDS OF LEAD LEGS. FINAL ANALYSIS ON THE LEAD (MODEL NO. 39565-65, SERIAL NO. (B)(4)) REVEALED NO SIGNIFICANT ANOMALIES. THE DISTAL END WAS NOT RETURNED. THE BODY INSULATION ON THE LEAD WAS CUT THRU. HOWEVER, THE CONTINUITY WAS ACCEPTABLE WITH NO SHORTS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD REVISION PERFORMED TO ATTEMPT TO INCREASE COVERAGE TO THE PATIENT'S RIGHT SIDE. DURING THE PROCEDURE, IT WAS NOT POSSIBLE TO MOVE OR REPOSITION THE PATIENT'S LEAD DUE TO THE PRESENCE OF SCAR TISSUE. THE LEAD WAS NOT IN THE "APPROPRIATE LOCATION." THE PATIENT'S DEVICE SYSTEM WAS, THEN, EXPLANTED. THERE WAS NO PATIENT INJURY. NO INFORMATION WAS PROVIDED RELATED TO THE PATIENT'S OUTCOME. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 47 YR Required Intervention LEAD: MODEL 39565-65, LOT # V611410044| RECHARGER: MODEL 37752, LOT # NKA150517N| PROGRAMMER: MODEL 37743, LOT # NKE162666N| IMPLANTED:| EXPLANTED: