BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4111407 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17590
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    September 2, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED OVER THE PAST MONTH THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) BEGAN TO TILT, STICK OUT, AND HAD CAUGHT ON CLOTHING AND EVERYDAY ACTIVITIES. THE INS HAD MOVED IN THE POCKET. THE PATIENT HAD AN APPOINTMENT WITH THEIR HEALTHCARE PROFESSIONAL (HCP) ON (B)(6) 2014. THE PATIENT WAS NOT RECEIVING A 50 PERCENT OR GREATER SYMPTOM REDUCTION AND THEY HAD DISCOMFORT AT THE DEVICE POCKET FROM IT CATCHING ON THINGS. AT THE APPOINTMENT THE HCP EXAMINED THE POCKET SITE. IMPEDANCES WERE CHECKED AND THEY WERE WITHIN NORMAL LIMITS. THE PATIENT WAS GIVEN A PRESCRIPTION FOR NUMBING MEDICATION FOR THE POCKET SITE WHERE THE INS WAS BOTHERING THE PATIENT. THE PATIENT WAS INSTRUCTED TO FOLLOW UP WITH THEIR IMPLANTING PHYSICIAN. IT WAS MENTIONED THERE WAS NO FALL OR WEIGHT LOSS ASSOCIATED WITH THE EVENT. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND PROGRAMMING CHANGES WERE NOT NEEDED. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE ISSUE WAS NOT DETERMINED. A REVISION OF THE INS BATTERY SITE WAS PLANNED AFTER THE PATIENT WAS MEDICALLY CLEARED. THE PATIENT STATUS WAS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GIVEN THE OPTION TO LIVE WITH SIGNS AND SYMPTOMS (S/S) VERSUS SX (REVISION OF SPINAL CORD STIMULATION BATTERY SITE). THE CAUSE OF THE EVENT WAS NOT DETERMINED. IT WAS NOT KNOWN IF IT WAS DEVICE RELATED. THE PATIENT¿S STATUS WAS UNKNOWN. LATER, IT WAS REPORTED THAT THE PATIENT WAS LAST SEEN BY THE HCP ON (B)(6) 2014 AND WOULD BE GETTING A REVISION SURGERY ON (B)(6) 2015. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED FOR THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REVISION TOOK PLACE (B)(6) 2014. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS MOVED TO A NEW LOCATION. THERE WERE NO DEVICES EXPLANTED. THE PATIENT WAS DISCHARGED AND WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589993 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 00037 YR Required Intervention