BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2892453 · Received January 2, 2013

    Report

    Report Number
    3004209178-2013-00022
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 10, 2012
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: NO ANOMALIES FOUND. THE INS PASSED FUNCTIONAL TESTING. ACCORDING TO THE TRACE REPORT TAKEN FROM THE INS, THE PATIENT RECHARGED THE BATTERY TO FULL ON (B)(6) 2012. ALSO ACCORDING TO THE TRACE REPORT THERE WAS GOOD COUPLING RECORDED 5-7 MINUTES INTO THE RECHARGE SESSIONS (4 OUT OF 5 SESSIONS HAD 8 BARS, AND 1 OUT OF 5 SESSIONS HAD 4 BARS). BASED ON THIS INFORMATION IT APPEARS RECHARGING WAS DONE APPROPRIATELY, HOWEVER, THE FACT OF HAVING TO RECHARGE FAIRLY OFTEN APPEARS TO BE DUE TO THE HIGH NUMBER OF ACTIVE ELECTRODES ALONG WITH HIGHER SETTINGS. ON GROUP A, PROGRAM 1 HAD ALL 8 ELECTRODES ACTIVE AND PROGRAM 2 HAD 7 ACTIVE ELECTRODES. THIS WOULD HAVE CONTRIBUTED TO A FAIRLY QUICK DRAIN ON THE BATTERY. FINAL DEVICE ANALYSIS OF THE PLUG REVEALED THE FOLLOWING: NO ANOMALIES FOUND. THE PLUG IS OKAY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3986A LOT# N191031, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3986A LOT# N191031, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708260 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW DETERMINED THIS EVENT WAS ALSO REPORTED UNDER MFR. REP. # 3004209178-2012-10534. ALL FUTURE FOLLOW-UP WILL BE CONDUCTED UNDER THIS MFR. REP. (#3004209178-2013-00022). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE BATTERY WAS DAMAGED DUE TO MULTIPLE OVERDISCHARGES, AND THE PATIENT LOST THERAPY. THE INS WAS REPLACED DURING OUTPATIENT SURGERY, AND IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HER IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED BECAUSE, SHE WAS RECHARGING IT TOO OFTEN (EVERY TWO DAYS). IT WAS SUSPECTED THAT THE PATIENT WAS NOT CHARGING "RESPONSIBLY". THERAPY WAS REPORTED TO BE GREAT OTHERWISE. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. THE REPORTER INDICATED THAT THE PATIENT WAS HAPPY WITH HER NEW INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141 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