BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3413662 · Received October 16, 2013

    Report

    Report Number
    3004209178-2013-19185
    Event Type
    Malfunction
    Date Received
    October 16, 2013
    Report Date
    September 26, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3888-45, LOT# V143279, IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37082-20, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3888-45, LOT# V250535, IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BEING JOLTED BY THE 0-3 SUBCUTANEOUS LEAD AND THIS HAD STARTED IN MARCH PRIOR TO THIS REPORT. IT WAS NOTED THAT THE CALLER ALSO MENTIONED IT HAD STARTED 3 MONTHS BEFORE JULY WHICH DID NOT MATCH THE GIVEN DATE. PATIENT FELT A JOLTING AT THE INCISION SITE WHERE THE LEAD WAS INTRODUCED WHEN THAT LEAD WAS ACTIVATED. IMPEDANCES WERE BETWEEN 1300-1400 OHMS AND GROUP IMPEDANCES WERE PROGRAM 1 233 OHMS, PROGRAM 2536 OHMS. IT WAS FURTHER NOTED THAT THE HEALTHCARE PROFESSIONAL (HCP) HAD DONE SOME IMAGING BUT HAD FOUND NO APPARENT SYSTEM PROBLEMS. IT WAS NOTED THAT THE JOLTING SENSATION WAS PRESENT WHETHER THE 0-3 LEAD WAS PROGRAMMED INDEPENDENTLY OR PROGRAMMED TO ¿CROSS-TALK¿ WITH THE OTHER LEADS. EXTENSIVE REPROGRAMMING WAS ATTEMPTED BUT HAD NOT RESOLVED THE ISSUE. INFORMATION OMITTED, SEE RELATED PE 700422738. ADDITIONAL INFORMATION RECEIVED REPORTED IMPEDANCES WERE IN RANGE AND THERE WAS SHARP PAIN USING THE SUBCUTANEOUS LEADS. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT WOULD BE GETTING A REVISION IN THE NEAR FUTURE BUT NOTHING WAS SCHEDULED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530899 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR