BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1000054 · Received February 15, 2008

    Report

    Report Number
    3004209178-2008-00689
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    September 21, 2007
    Report Date
    January 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    .

    Description of Event or Problem · 1

    THE HCP REPORTED IN 2007, THAT THE PATIENT HAD EXPERIENCED A LACK OF THERAPY BENEFIT; THE SYSTEM HAD NOT PROVIDED ADEQUATE PAIN CONTROL. INITIALLY THE SYSTEM HAD CONTROLLED SYMPTOMS BUT SUBSEQUENTLY HAD LOST EFFECTIVENESS; THE PATIENT HAD BEEN DISSATISFIED WITH DEVICE PERFORMANCE. SUBSEQUENTLY, THE PATIENT EXPERIENCED DRAINAGE FROM THE GENERATOR SITE; THE IPG REQUIRED EXPLANT AND THE PT REQUESTED TOTAL SYSTEM REMOVAL. SYSTEM REPLACEMENT WAS NOT ANTICIPATED. ADDITIONAL INFORMATION REPORTED ON 01/15/2008, SHOWS THE EVENT HAD BEEN ATTRIBUTED TO THE STIMULATOR; THE DRAINAGE FROM THE POCKET SITE HAD BEEN RELATED TO AN INFECTION. IT WAS UNK IF ANY PRODUCT WOULD BE RETURNED FOR ANALYSIS. THE PT HAD RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention EXPLANTED| EXPLANTED| EXTENSION MODEL 37083 LOT# NKC006765N IMPLANTED| EXPLANTED| EXTENSION MODEL 37083 LOT# NKC005197N IMPLANTED| LEAD MODEL 3998 LOT# LB7870 IMPLANTED