BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2726867 · Received September 5, 2012

    Report

    Report Number
    3004209178-2012-07615
    Event Type
    Injury
    Date Received
    September 5, 2012
    Report Date
    August 2, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 748951 LOT#, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 748951 LOT#, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID, 3998 LOT# V052566, SERIAL#, IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6). PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT#, SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 748951 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 748951 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3998 LOT# V052566, IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS AN MRSA INFECTION. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR, LEAD, AND EXTENSION WERE EXPLANTED ON (B)(6) 2012. SIGNS AND SYMPTOMS INCLUDED TWO AREAS OF OPEN DRAINAGE AND FEVER. IT WAS NOTED THAT THERE WAS NO HOSPITALIZATION, AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S THORACIC SPINAL CORD STIMULATOR LEAD WAS REMOVED AND NOT REPLACED DUE TO INEFFECTIVENESS AND INCREASED WEAKNESS AND NEUROLOGICAL ISSUES. AFTER REMOVAL OF THE THORACIC LEAD, AN MRI WAS COMPLETED AND REVEALED THAT SOFT TISSUE AND FLUID HAD ACCUMULATED AROUND WHERE THE LEAD HAD BEEN PLACED AND WAS CONTRIBUTING TO THE PATIENT'S INCREASED WEAKNESS AND URINARY INCONTINENCE. PATIENT OUTCOME WAS NOT AVAILABLE AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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