BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2113773 · Received June 2, 2011

    Report

    Report Number
    3004209178-2011-03917
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    November 16, 2010
    Report Date
    May 5, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS OF THE IMPLANTABLE PULSE GENERATOR (IPG) (B)(4) REVEALED NO ANOMALIES, IPG IS FUNCTIONALLY OKAY. THERE WAS GOOD STABLE OUTPUT ON EVERY ELECTRODE PAIR REFERENCED TO THE #0 ELECTRODE USING THE PT'S LEAD CONFIGURATION AND THE OUTPUT MATCHED THE PROGRAMMED SETTINGS. FINAL DEVICE ANALYSIS OF THE LEAD (B)(4) REVEALED THE #2 CONDUCTOR WIRE BROKEN INSIDE OF THE CONNECTOR SLEEVE. THE OUTER INSULATION WAS CUT AND EXPOSED THE BREAK. THE #2 CIRCUIT WAS OPEN AND NO SHORTS WERE SEEN. FINAL DEVICE ANALYSIS OF THE EXTENSION (B)(4) REVEALED NO SIGNIFICANT ANOMALIES. THE EXTENSION WAS OKAY BUT CUT THROUGH (SUSPECTED EXPLANT DAMAGE). THE CONTINUITY WAS ACCEPTABLE WITH NO SHORTS SEEN. FINAL DEVICE ANALYSIS OF THE IPG PLUG REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RECHARGING ISSUE AND THAT THE PT REQUESTED REMOVAL OF THE DEVICE SYSTEM DUE TO PAIN AT THE IMPLANT SITE (ABDOMEN) AND NEED FOR AN MRI. IT WAS UNCERTAIN IF DEVICE PROBLEM WAS RELATED TO SYMPTOMS. HEALTH CARE PROVIDER REPORTED THERE WAS NO DEVICE MALFUNCTION AND A FULL WORK UP REVEALED NO CAUSE FOR LOWER ABDOMINAL PAIN AT IPG SITE. NO MRI WAS ACTUALLY NEEDED. AFTER REMOVAL, THE PT'S PAIN WAS MUCH LESS. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention EXTENSION: MODEL 37083, LOT# NKC010797N| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTERNAL DEVICE: MODEL 37751, LOT# UNKNOWN| STIM ACCESSORY: MODEL 3550-39, LOT# UNKNOWN| STIM ACCESSORY: MODEL PLUG/IPG, LOT# UNKNOWN| PROGRAMMER: MODEL 37742, LOT# NJD015303N| LEAD: MODEL 3487A, LOT# J0437289V