BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4243357 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21307
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 22, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT 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).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT铠DEVICE WAS MOVED FROM HIS RIGHT SIDE TO HIS LEFT SIDE AS SCHEDULED. THE DISCOMFORT WAS RELATED TO THE POSITION OF THE GENERATOR. THE PATIENT WAS DOING WELL AND WAS RECEIVING EFFECTIVE STIMULATION. NO TROUBLESHOOTING WAS DONE PRE-OPERATIVELY. THE MANUFACTURER REPRESENTATIVE (REP) HAD A ROUTINE APPOINTMENT WITH THE PATIENT NEXT WEEK FOR A POST-OPERATIVE VISIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TODAY THE PATIENT WAS TO UNDERGO A REVISION OF THE POCKET SITE OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) DUE TO THE COMPLAINT OF DISCOMFORT. IT WAS UNKNOWN HOW LONG THE PATIENT HAD BEEN HAVING THE POCKET DISCOMFORT FOR. IT WAS THOUGHT THAT THE PATIENT HAD LOST WEIGHT WHICH MAY HAVE CAUSED THE POCKET DISCOMFORT BUT THE REPORTER WAS UNSURE. AT THE TIME OF REPORT THE PATIENT WAS GETTING ¿DECENT¿ COVERAGE AND THERE WAS NO DEVICE ISSUE REPORTED. IT WAS NOTED THAT THE PHYSICIAN MAY ADD ANOTHER LEAD COMPONENT FOR BETTER COVERAGE FOR THE PATIENT. THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR OUTCOME REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726100 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 00045 YR Required Intervention