BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3023561 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04302
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 1, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3550-39 LOT#, EXPLANTED: 2013 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS FOR THE LEAD REVEALED CONDUCTORS 1, 3 AND 7 WERE BROKEN AT THE ANCHOR SITE, 12.5CM FROM THE DISTAL END. FINAL DEVICE ANALYSIS FOR THE ANCHOR REVEALED NO ANOMALY FOUND.

    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 WAS NOT RECEIVING STIMULATION "AS USUAL". AN IMPEDANCE TEST SHOWED ELECTRODES 1-7 WERE ALL HIGH, OU T-OF-RANGE IMPEDANCE VALUES. THE REPORTER INDICATED THAT IT WAS NOT POSSIBLE TO EFFECTIVELY REPROGRAM THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THE EVENT BUT THE LEAD WAS CONSEQUENTLY EXPLANTED AND REPLACED WITH A NEW LEAD. PER MANUFACTURER'S DEVICE REGISTRY, THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ALSO REPLACED ON THE SAME DAY AS THE LEAD REPLACEMENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THERE WERE NO ISSUES WITH THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT'S HEALTHCARE PROVIDER (HCP) WANTED TO REPLACE THE INS AS WELL AS THE LEAD IN ORDER TO SAVE THE PATIENT ADDITIONAL SURGERY SINCE THE INS WAS GOING TO BE AT END-OF-LIFE (EOL) IN A COUPLE OF YEARS. THE ISSUES WERE REPORTEDLY RESOLVED AND THE PATIENT WAS GETTING GOOD COVERAGE POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127224 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention