BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3113627 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07695
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 39565-65, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. NO DEVICE ANALYSIS WAS PERFORMED; THE DEVICE MET RISK-BASED ANALYSIS CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    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 HAD ALL OF HER COMPONENTS REMOVED TWO WEEKS PRIOR TO REPORT DUE TO AN INFECTION. IT WAS NOTED THAT THE INFECTION WAS LOCATED AT THE "IMPLANTABLE NEUROSTIMULATOR (INS) LOCATION AND SPINE." IT WAS NOTED THAT THE INFECTION STARTED TWO WEEKS AFTER IMPLANT. IT WAS FURTHER NOTED THAT THERE WERE SYMPTOMS BUT THERE WAS NO ADDITIONAL INFORMATION GIVEN ON THE SYMPTOMS AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT NO INJURIES WERE NOTED AND THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214197 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 Required Intervention