BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3232821 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11939
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 23, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 97791, LOT# N370157, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD INTERMITTENT STIMULATION AND REPORTED A SHOCKING OR JOLTING SENSATION. IT WAS STATED THE PATIENT COMPLAINED OF SHOCKING WHEN THEIR STIMULATION WAS TURNED ON WITH MOVEMENT. IT WAS NOTED THE PATIENT WAS SCHEDULED FOR A REVISION FOR (B)(6) 2013. IT WAS STATED THE PATIENT HAD SYMPTOMS OF PAIN. IT WAS LATER REPORTED THE PATIENT WAS IN THE EMERGENCY ROOM (B)(6) 2013 BECAUSE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) ¿WOULDN'T SHUT OFF AFTER SHE SHUT IT OFF." IT WAS STATED THE DEVICE WAS A ¿DEFECTIVE PIECE OF EQUIPMENT.¿ IT WAS LATER REPORTED THE PATIENT WAS SCHEDULED TO MEET WITH THEIR MANUFACTURER REPRESENTATIVE THE DAY AFTER REPORT. IT WAS LATER REPORTED THE PATIENT¿S INS WAS REPOSITIONED IN THE POCKET TO IMPROVE COMFORT. IT WAS STATED THE CAUSE OF THE ISSUE WAS THE PATIENT HAD DISCOMFORT AT THEIR POCKET SITE AS WELL AS INCREASES IN STIMULATION WHILE WALKING. IT WAS NOTED THE PATIENT¿S COMFORT AT THEIR POCKET SITE IMPROVED AND THEIR ADAPTIVE STIMULATION WAS TURNED OFF FOR THE ¿UPRIGHT AND MOBILE¿ SETTING BECAUSE IT WAS CAUSING AN INCREASE IN STIMULATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER STATED THE CAUSE OF THE EVENT WAS THE PATIENT WAS CONFUSED ABOUT THEIR PROGRAMMER. IT WAS STATED THERE WERE NO ABNORMAL IMPEDANCES AND REPROGRAMMING WAS PERFORMED. IT WAS ALSO REPORTED THE BATTERY WAS REVISED AND PLACED IN A DEEPER LOCATION. REPORTEDLY, THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THEIR OUTCOME WAS REPORTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333183 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 00052 YR Required Intervention