BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3140881 · Received June 3, 2013

    Report

    Report Number
    3007566237-2013-01825
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG.
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3487A-33, LOT# J0230860V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7495LZ25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7435, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. CORRECTION: MANUFACTURING ID SHOULD BE (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. PRODUCT ID: 3487A, SERIAL# UNKNOWN, PRODUCT TYPE:LEAD. (B)(4).

    Description of Event or Problem · 1

    PAREKH, J., PATEL, S., ECKMANN, M., RAMAMURTHY, S. THORACIC WALL PAIN FROM SPINAL CORD STIMULATOR ELECTRODE MALFUNCTION. UNIVERSITY OF TEXAS SAN ANTONIO HEALTH SCIENCE CENTER, SAN ANTONIO, TX. THE JOURNAL OF PAIN. ABSTRACTS. SUMMARY/REPORTED EVENT: A 51-YEAR-OLD FEMALE PATIENT HAD EXCELLENT PAIN RELIEF UNTIL 14 MONTHS AFTER INITIAL IMPLANTATION, WHEN THE DEVICE WAS REVISED DUE TO INCREASING VOLTAGE DEMANDS. ELECTRODES WERE REPLACED. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243964 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG. 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention