BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3843343 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09963
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37714, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THE PATIENT HAD A POWER ON RESET (POR). IT WAS FURTHER NOTED THE PATIENT HAD TWO IMPLANTABLE NEUROSTIMULATORS (INS), ONE CERVICAL AND ONE LUMBAR. THE REPORTER STATED THAT BOTH DEVICES HAD A POR MESSAGE. THE REPORTER FURTHER STATED THE CERVICAL INS HAD AN INFORMATIONAL POR AND THE LUMBAR INS HAD A WARNING POR. IT WAS NOTED THE PATIENT FELT A JOLTING IN THEIR NECK AND ARMS. IT WAS FURTHER NOTED THAT BOTH OF THE PATIENT DEVICES WERE OFF. IT WAS NOTED THAT A MANUFACTURING REPRESENTATIVE WOULD MEET WITH THE PATIENT AND CLEAR THE POR WITH A CLINICIAN PROGRAMMER. IT WAS FURTHER NOTED THE INSS WERE CHARGED 90% AND WERE NOT LOW. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD AN OVERSTIMULATION AND SHOCKING AND JOLTING SENSATION. IT WAS NOTED THE PATIENT GOT A POR MESSAGE ON EACH INS TWO DAYS AGO. IT WAS FURTHER NOTED THE PATIENT STARTED TO FEEL A JOLTING/JERKING/SHAKING IN THEIR ARMS. THE REPORTER STATED THEY HAD AN APPOINTMENT TO MEET WITH THE PATIENT ON MONDAY. THE REPORTER FURTHER STATED THEY MET WITH THE PATIENT LAST NIGHT AND CHECKED BOTH INS WITH THE CLINICIAN PROGRAMMER. IT WAS NOTED THAT BOTH INS HAD A 0X8 POR. IT WAS FURTHER NOTED THE MANUFACTURING REPRESENTATIVE CLEARED THE PORS AND RESET EVERYTHING, BUT THE PATIENT STILL FELT THE JOLTING/JERKING/SHAKING IN THEIR ARMS. THE REPORTER STATED THEY DID A SHORT PHYSICIAN MODE RECHARGE (PMR) ON THE LEFT INS AND THE PATIENT¿S SYMPTOMS IMMEDIATELY STOPPED. THE REPORTER FURTHER STATED THEY TOLD THE PATIENT TO KEEP THE INSS OFF THROUGH THE NIGHT AND TO RECHARGE THE RIGHT INS. IT WAS NOTED THE RIGHT INS WAS CURRENTLY 75% AND THE LEFT INS WAS FULLY CHARGED. IT WAS FURTHER NOTED THE MANUFACTURING REPRESENTATIVE CHECKED THE SETTINGS AND TURNED THE INSS BACK ON. IT WAS FURTHER NOTED THE PATIENT HAD URODYNAMIC TESTING TWO WEEKS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321112 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 00022 YR