BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4243299 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21301
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 15, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3550-29, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY; PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4). NO DEVICE ANALYSIS WAS PERFORMED; THE DEVICE MET RISK BASED CRITERIA.

    Additional Manufacturer Narrative · 1

    ADDITIONAL ANALYSIS OF THE LEAD REVEALED THE DISTAL END OF THE CONDUCTOR WAS BROKEN.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE LEAD REVEALED THE DISTAL END OF THE ELECTRODE WAS PULLED OUT OR OFF. THE # 0 AND 1 ELECTRODE WERE MISSING FROM THE LEAD.

    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 THERE WAS AN UNPLANNED REVISION. THE PATIENT INITIALLY HAD ONE LEAD PLACED IN THE CERVICAL AREA TO ADDRESS LEFT ARM ISSUES BUT THE ISSUES MIGRATED TO THE RIGHT SIDE SO ANOTHER LEAD WAS PLACED TO ADDRESS THE ISSUE. THE ISSUES MIGRATING TO THE RIGHT SIDE WAS NOT CONSIDERED A DEVICE RELATED ISSUE, INSTEAD IT WAS NOTED AS DISEASE PROGRESSION. THE PAIN WAS CONSIDERED NEW PAIN OTHER THAN WHAT THE STIMULATOR WAS IMPLANTED FOR. THEY HAD ATTEMPTED TO REPROGRAM TO CAPTURE THAT SIDE BUT WERE UNSUCCESSFUL. THE STIMULATOR WAS STILL COVERING THE ORIGINAL PAIN AREA. DURING PROGRAMMING TWO ELECTRODES WERE NOTED AS OUT OF RANGE. THE CONTACTS HAD ALSO PREVIOUSLY BEEN SHOWING OUT OF RANGE. THE LEAD HAD TWO CONTACTS THAT WERE FLOATING AND THE LEAD WAS FRACTURED/BROKEN. INTRA-OPERATIVE X-RAY REVEALED THE TOP TWO ELECTRODES WERE COMPLETELY SEVERED FROM THE REST OF THE LEAD, HOWEVER THE OTHER SIX WERE STILL WORKING. THE CONTACTS HAD NOT BEEN USED IN THE PAST. THE LEAD WAS EXPLANTED AND REPLACED AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE. POST-OPERATIVELY THE PATIENT HAD RIGHT AND LEFT ARM COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725454 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 00052 YR Required Intervention