BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2854139 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11049
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 5, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (SERIAL # (B)(4)) FOUND THAT THE PROXIMAL END CONNECTOR WAS NOT COMPLETELY SEATED IN THE INS CONNECTOR PORT. BASED ON THE LOCATION OF THE SETSCREW MARKS ON THE CONNECTOR SLEEVES, THE LEAD WAS NOT FULLY INSERTED INTO THE INS CONNECTOR BLOCK. SETSCREW MARKS ARE VISIBLE ON THE #0 AND #1 CONNECTOR SLEEVES. THE #0 SETSCREW MARKS ARE TOO PROXIMAL AND ARE ON THE EDGE OF THE SLEEVE. THERE ARE TWO SETSCREW MARKS VISIBLE ON THE #8 CONNECTOR SLEEVE. ONE IS CORRECT AND THE OTHER IS TOO PROXIMAL AND ON THE EDGE OF THE SLEEVE. A FUNCTIONALITY TEST WAS CONDUCTED AND THERE WERE NO SHORTS (DRY) AND THE CONTINUITY WAS ACCEPTABLE.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON THREE ELECTRODES OF HIS LEAD. WHEN THE IMPEDANCES WERE HIGH DURING IMPLANT, THE PHYSICIAN REMOVED THE LEADS, WIPED THEM DOWN, AND SWITCHED THE PORTS. CHANGING PORTS RESULTED IN DIFFERENT ELECTRODES BEING "OUT-OF-RANGE." THIS PROCESS WAS REPEATED AND THE READINGS REMAINED INCONSISTENT. THE PATIENT WAS RECEIVING LEFT-SIDE STIMULATION, BUT GOT NO RIGHT-SIDE COVERAGE. IT WAS STATED THAT THE PATIENT WOULD BE SCHEDULED FOR A REVISION, THOUGH IT WAS NOTED THAT THERE WAS NO INJURY OR ADVERSE EVENT. EIGHT DAYS LATER, IT WAS REPORTED THAT THE PATIENT'S LEAD WAS REMOVED ON (B)(6) 2012. IT WAS REPLACED AND "ALL EQUIPMENT SHOWED NORMAL LEVELS." IT WAS NOTED THAT NO ADVERSE EVENTS OCCURRED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 00070 YR Required Intervention