BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3173777 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10495
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 28, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAD MIGRATION AND IMPEDANCES OVER 40,000 OHMS. IT WAS NOTED THAT THE BATTERY WAS DRAINING FASTER THAN WHEN IT WAS IMPLANTED. IT WAS REPORTED THAT THERE WERE NO PATIENT SYMPTOMS / INJURIES RELATED TO THE EVENT, AND THE PLAN WAS FOR A LEAD REVISION. IT WAS LATER REPORTED THAT THE REVISION HAD NOT YET BEENSCHEDULED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED INDICATED THAT 2 LEADS HAD BEEN REPLACED AND THE PATIENT HAD COVERAGE OF LEFT LOWER EXTREMITY. NO ANALYSIS WAS REQUESTED AND THE LEADS WERE DISPOSED PER SURGEON'S REQUEST.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S REVISION WAS SCHEDULED FOR (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THAT THE LEAD DISLODGEMENT/MIGRATION FROM T9/10 TO T2. SYMPTOMS ASSOCIATED WITH THE EVENT INCLUDED MINIMAL STIMULATION IN PAINFUL AREAS. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT. PATIENT OUTCOME WAS NO INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALL ELECTRODES SHOWED OUT OF RANGE IMPEDANCES. IT WAS UNKNOWN WHAT THE ISSUE WAS DUE TO, THAT WAS FROM THE LEAD/EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273917 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 00033 YR Required Intervention