BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 2854867 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11080
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 7, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7439 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 377860 LOT# V010208, IMPLANTED: 2006 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 355029 LOT# N075638, IMPLANTED: 2006 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE SYSTEM "HAD NOT WORKED" FOR A LONG TIME AND THE IMPLANTABLE NEUROSTIMULATOR HAD BEEN REMOVED. THE REPORTER STATED THAT THE LEAD HAD NOT BEEN REMOVED. IT WAS REPORTED THAT THE PHYSICIAN WANTED TO KNOW IN WHAT CONDITION THE PATIENT COULD HAVE AN MRI. A WEEK LATER, PER MANUFACTURER DEVICE REGISTRATION, THE LEAD WAS REMOVED ON (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE HEALTH CARE PROFESSIONAL HAD NOT EXPLANTED ANYTHING AND THE LAST TIME THE PATIENT HAD BEEN SEEN WAS (B)(6) 2011. THE PATIENT HAD BEEN HAVING HIGH IMPEDANCES BUT THEY HAD NEVER DETERMINED WHY. IT WAS NOTED THE SAME THING HAPPENED IN 2010 WITH HIGH IMPEDANCES. IT WAS NOTED THE PATIENT NEVER WENT BACK TO THE HEALTH CARE PROFESSIONAL IN EITHER INSTANCE. THE HEALTH CARE PROVIDER HAD NO FURTHER INFORMATION ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention