BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3841395 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09930
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 6, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3550-29, LOT# N449045, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF A PATIENT¿S CERVICAL LEAD WHEN THE PATIENT WAS IN THE PRONE POSITION AND THE MANUFACTURER¿S REPRESENTATIVE HAD TO CRANK THE DEVICE UP TO 4 VOLTS FOR THE PATIENT TO FEEL IT. IT WAS NOTED THAT THE MANUFACTURER¿S REPRESENTATIVE STATED THAT THIS SEEMED TO BE ABNORMAL THAT SHE HAD TO RAISE THE VOLTAGE THAT HIGH. IT WAS STATED THAT IMPEDANCES WERE ¿GREAT¿ ¿ ALL BETWEEN 400 AND 800 OHMS. IT WAS STATED THAT THE HEALTHCARE PROFESSIONAL (HCP) TOOK A LATERAL VIEW OF THE LEAD AND THE MANUFACTURER¿S REPRESENTATIVE WAS CONCERNED THAT IT WAS AN ANTERIOR PLACEMENT. IT WAS NOTED THAT THE HCP WAS NOT CONCERNED. IT WAS REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE MET WITH THE PATIENT POST-OP TO DO PROGRAMMING. IT WAS REPORTED THAT ¿NO MATTER WHERE SHE STIMULATED ON THE LEAD, WHEN SHE GOT TO .4 OR .5 VOLTS THE PATIENT GOT EXCRUCIATING SHARP NECK PAIN¿. IT WAS NOTED THAT THE MANUFACTURER¿S REPRESENTATIVE DID NOT WANT TO DO IMPEDANCES AGAIN AS THE DEFAULT WAS .7 VOLTS. IT WAS NOTED THAT THE HCP ¿KEPT SAYING SHE WOULD HAVE MOTOR STIMULATION AND ABDOMINAL PAIN IF THE LEAD WERE IN THE WRONG LOCATION¿ BUT THE MANUFACTURER¿S REPRESENTATIVE THOUGHT ¿NOT NECESSARILY¿. IT WAS NOTED THAT THE CALLER WAS REDIRECTED TO THE HCP TO ¿FIGURE OUT WHAT WAS GOING ON¿. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS INSTRUCTED TO LEAVE STIMULATION OFF UNTIL THE FOLLOW UP VISIT IN 2 WEEKS. IT WAS STATED THAT THE MANUFACTURER¿S REPRESENTATIVE WOULD SEE THE PATIENT THEN AND EVALUATE FURTHER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A REVISION PROCEDURE LAST TUESDAY. IT WAS STATED THAT THE PRESENT LEAD WAS REPOSITIONED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING VERY WELL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS "DOING GREAT" AFTER THE REVISION AND HAD GREAT COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317991 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 00042 YR Required Intervention