BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2652872 · Received July 12, 2012

    Report

    Report Number
    3004209178-2012-05489
    Event Type
    Malfunction
    Date Received
    July 12, 2012
    Report Date
    June 14, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# V123485, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS CHARGING MORE THAN EXPECTED. SHE USED TO BE ABLE TO CHARGE EVERY 2-3 WEEKS, BUT AT THE TIME OF THE EVENT, SHE HAD TO RECHARGE EVERY 2-3 DAYS. SOMETIMES AFTER SHE GOT PAST 75%, IT WOULD TAKE LONGER TO FILL LAST QUARTILE AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WOULD "OVERHEAT ," THEN IT WOULD HAVE TO COOL OFF. SHE WAS CHARGING 4-6 HRS AT A TIME. THE IMPEDANCES WERE AS FOLLOWS: TAKEN AT 1.5V. 0, 1 >20 ,000 OHMS, ALL REFERENCE ELECTRODES SHOWED 0/1 >20,000 WITH RANGES AS FOLLOWS: 2: 580-940, 2: 618-1066, 3: 618-1066, 8: 934-1066, 9:861-1055, 10: 580- 934, 11: 618-951. ALL IN OHMS. CALCULATED ESTIMATED RECHARGE INTERVAL ON LONGEVITY CALCULATOR. PROG: 2+,3- ,8+,9+,10+,11-, 5.4V, 450PW, 60HZ, CYCLING: 8 MIN ON/1 MIN OFF, THERAPY IMPEDANCE =347 OHMS. ESTIMATED RECHARGE INTERVAL= 5.46 DAYS. THE RECHARGE STATISTICS SHOWED ONLY 3 DAYS OF CHARGING DATA WITH MULTIPLE ATTEMPTS ON TWO DAYS. THE INS WAS TAKING A CHARGE AND THE PATIENT HAD DATES FROM (B)(6) 2012 (8 DAYS) WHERE SHE WENT FROM 100% CHARGED TO 0% CHARGED. BECAUSE OF THE NUMEROUS ATTEMPTS ON ONE DAY AND WITH NO COUPLING, IT WAS DIFFICULT TO MAKE ANY ASSUMPTIONS ON HER CHARGING. ONE OF THE ELECTRODES WERE REMOVED, BUT COVERAGE WAS NOT AS GOOD AS CURRENTLY PROGRAMMED. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS EVENT WAS CAUSED BY AN INCREASE IN THE ENERGY REQUIREMENTS FOR THE DEVICE. IT WAS NOTED THAT CONTACT 0 AND 1 REPORTED IMPEDANCE MEASUREMENTS GREATER THAN 10,000 OHMS. IT WAS INDICATED THAT THE ISSUE WITH THE INTERNAL NEUROSTIMULATOR (INS) WAS UNKNOWN. NO SURGICAL INTERVENTION WAS REPORTED. THE PATIENT WAS NOT HOSPITALIZED DUE TO THIS EVENT. NO PATIENT INJURY WAS REPORTED. IT WAS NOTED THAT THE PATIENT NEEDED TO CHARGE MORE FREQUENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1