BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2639085 · Received July 3, 2012

    Report

    Report Number
    3004209178-2012-05186
    Event Type
    Injury
    Date Received
    July 3, 2012
    Report Date
    June 5, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD: MODEL 377845, LOT# V013536, IMPLANTED: (B)(6) 2007, EXPLANTED: NA; LEAD: MODEL 377845, LOT# V013536, IMPLANTED: (B)(6) 2007, EXPLANTED: NA; EXTENSION: MODEL 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: NA; EXTENSION: MODEL 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: NA; PROGRAMMER: MODEL 37742, SERIAL# (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THE INS WAS RECEIVED IN AN OVER DISCHARGED STATE. ACCORDING TO THE TRACE REPORT TAKEN FROM THE INS, IT WAS RECHARGED ON (B)(4) 2008 AND (B)(4) 2008 AND THEN NOT RECHARGED UNTIL (B)(4) 2009. THE LAST RECHARGE DONE WHILE THE INS WAS IMPLANTED WAS ON (B)(4) 2009. THE INS WENT TO THE LOCK MODE ON (B)(4) 2009. IT WAS NOT AGAIN RECHARGED UNTIL ONE FULL PHYSICIAN MODE WAS DONE IN THE ANALYSIS LAB AND THE TELEMETRY WAS RETURNED. AFTER THE TELEMETRY WAS RESTORED, THE INS FUNCTIONED PROPERLY.

    Additional Manufacturer Narrative · 1

    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

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED PATIENT DID NOT CHARGE THE DEVICE OVER SEVERAL OCCURENCES. IT WAS ALSO REPORTED DEVICE WAS REPLACED (B)(6) 2012 - DAY WAS NOT SPECIFIED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT FAILED TO CHARGE HER DEVICE AND WAS UNABLE TO DO A TRICKLE CHARGE. THE PATIENT WAS SCHEDULED FOR A REPLACEMENT SURGERY. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TELEMETRY ISSUES. AN INS OVERDISCHARGE WAS SUSPECTED. THE PATIENT STATED THAT THE BATTERY WOULDN'T HOLD A CHARGE, THOUGH IT WAS NOTED THAT INFORMATION PROVIDED BY THE PATIENT MAY HAVE BEEN INACCURATE. SEVERAL PHYSICIAN MODE RECHARGES WERE ATTEMPTED WITHOUT SUCCESS. NO OTHER TROUBLESHOOTING OR INTERVENTIONS WERE PERFORMED, AND IT WAS REPORTED THAT THE PATIENT PLANNED TO DISCUSS THE NEXT STEPS WITH HER PHYSICIAN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE NORMAL BATTERY DEPLETION OCCURRED. IT WAS NOTED THAT THE PATIENT REQUESTED A BATTERY REPLACEMENT AND THE DEVICE WAS EXPLANTED ON (B)(6) 2012. NO PATIENT INJURY WAS REPORTED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention