BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3771484 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08088
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 4, 2014
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37746, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A DISCHARGED BATTERY, ¿ACTUALLY OVERDISCHARGED¿. IT WAS STATED THAT THE CALLER HAD DONE 4-5 PHYSICIAN MODE RESTARTS (¿PRM¿S) ALREADY AND IT HAD NOT STARTED TO CHARGE NORMALLY. IT WAS STATED THAT THE PATIENT LAST FELT STIMULATION IN (B)(6) 2014 AND THE LAST TIME HE CHARGED WAS BEFORE THAT. IT WAS STATED THAT THE PATIENT HAD BEEN IMPLANTED IN (B)(6) 2013 AND THAT THE RECHARGING SESSIONS WERE DONE ¿ALMOST IN A ROW¿. IT WAS NOTED THAT THE MANUFACTURER¿S REPRESENTATIVE WAS MADE AWARE ¿LAST FRIDAY¿ (2014 (B)(6)). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE OVERDISCHARGE HAD BEEN CAUSED BY PATIENT NONCOMPLIANCE. IT WAS STATED THAT THE PMR WAS NOT SUCCESSFUL. IT WAS REPORTED THAT THE PATIENT WAS BEGINNING TO FEEL HIS ORIGINAL PAIN. IT WAS STATED THAT NO FURTHER TROUBLESHOOTING OR INTERVENTIONS HAD BEEN NECESSARY. IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A REPLACEMENT (B)(6). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD BEEN SCHEDULED FOR REPLACEMENT FOR TODAY, BUT CANCELLED. IT WAS STATED THAT THEY WOULD RESCHEDULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248965 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