BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3173741 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10492
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 28, 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

    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS OF THE LEAD FOUND NO SIGNIFICANT ANOMALY. THE LEAD BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED. ANALYSIS OF TITAN ANCHOR 1 FOUND NO ANOMALY. ANALYSIS OF TITAN ANCHOR 2 FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3550-39, LOT# N331050, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (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 PATIENTS DEVICE WAS IN OVERDISCHARGE. A COMPANY REPRESENTATIVE PERFORMED A DEEP CYCLE CHARGE. THE PATIENT FELT STIMULATION IN THE RIBS AND ABDOMEN ONLY. STIMULATION WAS ADJUSTED, BUT IT DIDN¿T CHANGE FROM THE RIB/ABDOMEN LOCATION. THE PATIENT STATED THAT THE PHYSICIAN HAD TOLD HER THE LEAD HAD MOVED. THE PATIENT ALSO WANTED THE BATTERY MOVED AS THE POCKET HAD BEEN UNCOMFORTABLE. THE PATIENT HAD A 40 POUND WEIGHT LOSS. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A REVISION ON (B)(6) 2013. THE LEAD HAD MIGRATED UP TO T5. THE LEAD WAS REPLACED AND MOVED TO T8. THE PATIENT HAD NOT BEEN PROGRAMMED YET.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS REPROGRAMMED TO HAVE COVERAGE OF HER BACK AND LEFT LEG. THE PATIENT WAS SATISFIED WITH THE COVERAGE. THE PATIENT RECOVERED WITH NO SEQUELAE.

    Description of Event or Problem · 1

    FURTHER EVALUATION OF THE EVENT DETERMINED THAT A PORTION OF THE EVENT RELATED TO THE OVERDISCHARGE CONDITION ON THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN REPORTED IN MANUFACTURER¿S REPORT # 3004209178-2013-12125.

    Description of Event or Problem · 1

    PRIOR TO THE REVISION IT WAS NOTED THE IMPLANTABLE NEUROSTIMULATOR WAS ¿CATCHING ON CHAIRS¿ AND WAS PAINFUL. THE LEAD WAS NO LONGER PROVIDING RELIEF AS WELL. THIS WAS THE REASONING FOR THE PATIENT TO STOP CHARGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273833 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 Required Intervention