BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3517190 · Received December 12, 2013

    Report

    Report Number
    3004209178-2013-23480
    Event Type
    Injury
    Date Received
    December 12, 2013
    Report Date
    November 26, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 7752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. PRODUCT ID: 377860, LOT# V011672, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V011672, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V011672, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V011672, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT DEVICE INTERROGATION ON (B)(6) 2013 FOUND ON LEAD HAD HIGH IMPEDANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD SHOCKING PAIN IN THEIR CHEST AND HIGH IMPEDANCE ON ONE LEAD. IT WAS NOTED THE PATIENT¿S LEAD WAS REPLACED ON (B)(6) 2013. IT WAS FURTHER NOTED THE PATIENT WAS REPROGRAMMED ON (B)(6) 2013. IT WAS NOTED THAT AN EXAMINATION AND PALPATION ON (B)(6) 2013 FOUND THE PATIENT HAD SHOCKING PAIN IN THEIR CHEST. IT WAS FURTHER NOTED THAT A DEVICE INTERROGATION ON (B)(6) 2013 FOUND ONE LEAD HAD HIGH IMPEDANCES. IT WAS NOTED THE ETIOLOGY WAS RELATED TO THE DEVICE OR THERAPY AND UNLIKELY RELATED TO THE IMPLANT PROCEDURE. IT WAS FURTHER NOTED THE PATIENT SYMPTOMS WERE SHOCKING PAIN IN THEIR CHEST. IT WAS FURTHER NOTED THE PATIENT OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649989 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention