BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4153031 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18556
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 17, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3998, LOT# VA027YB, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 355531, LOT# N345625, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 3998, LOT# VA0G2FB, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT¿S LEAD BROKE/FRACTURED. ONE WIRE WAS SEVERELY DAMAGED AS SEEN ON X-RAY. THE LEAD WAS REPLACED AND GOOD IMPEDE CUES WERE OBSERVED WITH THE NEW LEAD. THE DAMAGED LEAD WAS EXPLANTED AND DISCARDED BY THE CUSTOMER AS A RESULT OF THE EVENT. NO OTHER DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS REQUIRED. THE PRODUCT ISSUE WAS RESOLVED. IT WAS NOTED THE LEAD WAS PLACED RETROGRADE AND WITH A TIGHT TURN AT THE ANCHOR. THE PATIENT WAS ALIVE WITH NO INJURY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS A VOMIT THREAT AND THEREFORE CAME OUT OF SURGERY WITH HER INTUBATION STILL IN PLACE AND FULLY SEDATED. A GOOD PROCEDURE FOR REPLACEMENT OF THE LEAD WAS NOTED. A MESSAGE WAS LEFT FOR THE PATIENT TO SEE IF THE COVERAGE WAS GOOD, BUT THERE HAD BEEN NO RESPONSE YET. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN MORE INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632151 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 Required Intervention