BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3112400 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07658
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 25, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS 37712 RESTOREULTRA, SERIAL # (B)(4)) FOUND ITS BATTERY HAVING A REDUCED CAPACITY DUE TO OVERDISCHARGE. THE INS WAS RECEIVED WITH THE BATTERY DEPLETED TO THE "LOCK" MODE. THE INS WAS RECHARGED AT BODY TEMPERATURE WITH 1 CM SPACING BETWEEN THE INS AND RECHARGE ANTENNA. IT RECHARGED FOR 1 HOUR 42 MINUTES AND STOPPED. THE BATTERY VOLTAGE WENT FROM 3.295 VOLTS UP TO 3.910 VOLTS (ABOUT 3/4 CHARGED). IT SAT OVERNIGHT WITH THE OUTPUT OFF AND THE BATTERY VOLTAGE DEPLETED TO 3.775 VOLTS. THIS WAS DUE TO THE FACT THAT THE BATTERY HAD REDUCED CAPACITY THAT WAS CAUSED BY AN OVERDISCHARGE THAT HAD OCCURRED AND WAS RECOVERED PRIOR TO BEING RECEIVED FOR ANALYSIS. ONE OVERDISCHARGE WAS REPORTED ON THE TRACE REPORT TAKEN FROM THE INS. THE DATE THAT IT HAD OCCURRED COULD NOT BE DETERMINED. THE REDUCED CAPACITY FROM THE OVERDISCHARGE IS THE REASON THAT THE INS REQUIRED MORE FREQUENT RECHARGING. THE LAST SIX RECHARGE SESSIONS SHOWN ON THE TRACE REPORT AND DIAGNOSTIC DATA, INDICATE THAT IT WAS RECHARGED ON (B)(6) 2013. THIS DID NOT INDICATE THAT IT WAS BEING RECHARGED TWICE PER DAY AS STATED IN THE EVENT. DURING THESE RECHARGE SESSIONS THE BATTERY ONLY CHARGED TO ABOUT 50 TO 75% WHICH IS CONSISTENT WITH WHAT WAS OBSERVED DURING ANALYSIS. SOME BATTERY CAPACITY WAS ABLE TO BE RESTORED IN THE ANALYSIS LAB SO THAT IT WAS RECOVERED TO THE POINT OF GETTING 100% CHARGE. THE INS PASSED FUNCTIONAL TESTING INDICATING THAT THE ONLY ISSUE WAS THE REDUCED BATTERY CAPACITY DUE TO OVERDISCHARGE. CONNECTOR MODULE HAD BEEN SCRATCHED. FOREIGN MATERIAL WAS FOUND IN CONNECTOR PORT. ACCESS HOLE ADHESIVE HAD A COSMETIC DEPRESSION. SHIELD/CAN HAD BEEN SCRATCHED. (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

    IT WAS REPORTED THAT THE BATTERY WAS NOT HOLDING A CHARGE AND THAT THE PATIENT HAD TO CHARGE IT TWICE A DAY. IT WAS NOTED THAT IMPEDANCES WERE NORMAL AND THAT THE PATIENT HAD GREAT COVERAGE FROM HER LEAD. IT WAS FURTHER NOTED THAT THE PATIENT WAS ALIVE WITH NO INJURY AND NO ADVERSE EVENT. IT WAS NOTED THAT REVISION WAS REQUIRED AS A RESULT OF THE EVENT. IT WAS NOTED THAT THE BATTERY WAS REPLACED. IT WAS FURTHER NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213292 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 Required Intervention