BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3295822 · Received August 19, 2013

    Report

    Report Number
    3004209178-2013-14810
    Event Type
    Injury
    Date Received
    August 19, 2013
    Report Date
    July 22, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 3487A-45 LOT# V845046, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3487A-45 LOT# V845046, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3776-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE STIMULATOR REVEALED THE STIMULATOR BATTERY CAPACITY WAS REDUCED DUE TO OVERDISCHARGE. THE STIMULATOR WAS RECEIVED WITH NO TELEMETRY. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE STIMULATOR AFTER PHYSICIAN MODE RECHARGE RECOVERY THE TOTAL RECHARGE COUNT WAS 224. THE LAST RECORDED RECHARGE SESSION PERFORMED WHILE THE DEVICE WAS IMPLANTED OCCURRED (B)(6) 2013. THE DEVICE WAS RECHARGED FOR 1 HOUR AND 41 MINUTES AND THE BATTERY CHARGED FROM 3.7 VOLTS TO 3.82 VOLTS. THE BATTERY DISCHARGED TO LOCK MODE ON (B)(6) 2013.

    Description of Event or Problem · 1

    2013 (B)(6) OC INTERFACE (HCP): IT WAS REPORTED THAT THERE WAS A BATTERY FLIP. THE PATIENT WAS UNABLE TO GET THE BATTERY TO CHARGE. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED AND THE PATIENT RECOVERED WITHOUT SEQUELA ON (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS UPSIDE DOWN IN THE INCISION. IT WAS NOTED THAT AN ATTEMPT WAS MADE TO RECHARGE BUT WAS UNABLETO RELIEVE DEEP DISCHARGE STATE. IT WAS NOTED THAT THE INS WAS REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS AN INABILITY FOR THE DEVICE TO RECHARGE. IT WAS NOTED THAT THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013. IT WAS NOTED THAT THERE WERE NO DIAGNOSTIC METHODS. IT WAS NOTED THAT THE EVENT WAS RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. IT WAS NOTED THAT THERE WERE NO SIGNS OR SYMPTOMS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IN A PROLONGED DISCHARGE AND COULD BE PROBLEMATIC FOR LONG TERM USE. THE PATIENT WAS UNABLE TO RECHARGE STIMULATOR DUE TO INVERSION TO SEQUELAE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399757 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention