BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3132416 · Received May 29, 2013

    Report

    Report Number
    3007566237-2013-01767
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 9, 2013
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3999, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT# J0357388V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 3998, LOT# J0357388V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 748940, SERIAL# (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD WAS NOT SAVED TO RETURN AND THE PATIENT WAS "DOING WELL WITH HER THERAPY."

    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: (B)(6) FEMALE PRESENTED WITH NEW LEFT SIDED CHEST PAIN WITH USAGE OF HER SPINAL CORD STIMULATOR (SCS) AFTER 7 YEARS. THE PATIENT ABRUPTLY STARTED TO EXPERIENCE LEFT SIDED CHEST WALL PAIN CONSISTENTLY DURING SCS ACTIVATION DESPITE MULTIPLE ATTEMPTS AT REPROGRAMMING. THERE WERE SIGNS OF DISCONTINUITY IN SOME CONTACTS. THE PATIENT WAS OFFERED ANOTHER REVISION WITH A NEW PADDLE ELECTRODE. DURING THE SURGERY, THE PATIENT¿S LEFT ELECTRODE APPEARED TO HAVE A DEFECT IN THE INSULATION. EXCELLENT RELIEF OF THE PATIENT¿S NEUROPATHIC PAIN WAS ACHIEVED WITH COMPLETE RESOLUTION OF THE THORACIC DYSESTHESIAS DURING STIMULATION. 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
    235760 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention