BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME

    MDR report key: 3087408 · Received May 1, 2013

    Report

    Report Number
    3004209178-2013-07130
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Report Date
    April 19, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR WAS EZW. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-28, LOT# VA03ZBP, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-28, LOT# VA03ZBP, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3093-28 LOT# VA03ZBP, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3093-28 LOT# VA03ZBP, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IF THE PATIENT BEGAN TO FEEL PAIN, THEY WOULD TURN IT (STIMULATION) BACK ON.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WOULD SHUT ITSELF OFF. IT WAS FURTHER REPORTED THAT THIS HAD OCCURRED "FOR ABOUT ONE MONTH" PRIOR TO REPORT. IT WAS STATED THAT WHEN THE PATIENT "USED A SMALLER PURSE AND HAD HER PATIENT PROGRAMMER IN IT, THE PURSE WOULD BE ABOUT A COUPLE FEET AWAY FROM HER IMPLANT AND IT WOULD TURN HER STIMULATION OFF." IT WAS FURTHER STATED THE PATIENT WOULD "HEAR THE BEEP AND WOULD NOT FEEL HER STIMULATION." IT WAS NOTED THE PATIENT THOUGHT SHE WOULD "PRESS THE SYNCH KEY TO CHECK IF THE LIGHTNING BOLT IS THERE AND CONFIRMS IT'S OFF." IT WAS FURTHER NOTED THAT THE PATIENT'S PHYSICIAN HAD NO SUGGESTIONS REGARDING THE ISSUE. ADDITIONAL INFORMATION STATED THE PATIENT THOUGHT "IT WAS AN ODD THING AND SOMETHING MUST BE WRONG" AND THAT IT WAS "BIZARRE THAT IT IS HAPPENING." THE PATIENT STATED "IT COULD HAVE BEEN GOING ALL ALONG" AND NOTED "SHE FIRST NOTICED IT STARTED OCCURRING RIGHT AFTER SHE HAD SURGERY AND WAS RECOVERING. THE PATIENT FURTHER STATED SHE FIRST NOTICED IT AT HOME, FIVE DAYS AFTER IMPLANT AND DIDN'T KNOW IT HAD BEEN OFF OR FOR HOW LONG." IT WAS REPORTED THE PATIENT SHOWED HER PHYSICIAN SHE WAS ABLE TO SHUT OFF HER DEVICE WHEN SHE "HELD THE PATIENT PROGRAMMER ALL THE WAY OUT AND SHE PUSHED THE MIDDLE BUTTON." IT WAS NOTED THE PATIENT "HAD DONE THIS WITHOUT USING THE ANTENNA OR HAVING IT ANYWHERE NEAR HER." IT WAS FURTHER REPORTED THE PATIENT HAD TO "TAKE THE ANTENNA OUT TO TURN IT BACK ON." THE PATIENT NOTED SHE HAD TO "LISTEN FOR THE BEEP TO KNOW IF THE INS MIGHT HAVE SHUT OFF." IT WAS STATED THE DEVICE WASN'T TOTALLY WORKING" FOR THE PATIENT AND THAT SHE "STILL HAD A LITTLE RETENTION." THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013 WITH A MANUFACTURER REPRESENTATIVE. THE PATIENT WAS REDIRECTED TO HER HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS REPROGRAMMED DUE TO PERSISTENT RETENTION. THE HEALTH CARE PROVIDER CONTACTED WAS NOT AWARE OF THE STIMULATION TURNING OFF ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188796 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1