BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2830665 · Received November 13, 2012

    Report

    Report Number
    3004209178-2012-10210
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    October 15, 2012
    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

    PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-39, LOT # N343398, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCES WERE >40000 OHMS ON CONTACTS 10 AND 11; ALL OTHER IMPEDANCES WERE "NORMAL." IT WAS ALSO REPORTED THAT DURING IMPLANT THE HEALTH CARE PROVIDER (HCP) HAD "MULTIPLE" STYLET INSERTIONS INTO THE LEAD AND WAS GETTING RESISTANCE TO INSERTION ABOUT TWO INCHES FROM THE END OF THE LEAD. EVENTUALLY A STYLET WAS SUCCESSFULLY INSERTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THE HCP TOOK FOUR HOURS TO PLACE THE LEADS, EVEN THOUGH THERE WERE A "HANDFUL" OF TIMES PLACEMENT "LOOKED GOOD." DURING THAT PROCESS THE STYLETS WERE REMOVED "IN AN OUT" OF EACH LEAD "20+" TIMES WITH BLOODY GLOVES. THE HCP "BURNED" THROUGH ACCESSORY KIT STYLETS DUE TO THEM BEING "BENT AND KINKED." AT THE END OF THE CASE INTRA OPERATIVE TESTING WAS PERFORMED WITH "GOOD" STIMULATION COVERAGE AND NO IMPEDANCE ISSUES, HOWEVER THE HCP MOVED THE LEADS. WHEN THE LEADS WERE FINALLY FINISHED BEING PLACED, THE IMPEDANCES OF ELECTRODES 10 AND 11 WERE >40000 OHMS. THE ELECTRODES WERE THOUGHT TO BE DAMAGED, BECAUSE ALL OTHER ELECTRODES HAD NORMAL IMPEDANCES. THE HCP STATED SHE COULD HAVE "NICKED" THE LEAD WHILE SUTURING. FURTHER INFORMATION RECEIVED ON (B)(4) 2012 REPORTED THAT DURING THE POST-OPERATIVE APPOINTMENT THERE WERE NO IMPEDANCE ISSUES AND THE PATIENT HAD "GOOD" COVERAGE WITH STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention