BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 5207543 · Received November 6, 2015

    Report

    Report Number
    3004209178-2015-22353
    Event Type
    Injury
    Date Received
    November 6, 2015
    Date of Event
    January 1, 2014
    Report Date
    August 20, 2017
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 3998, LOT# V110880, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3550-09, LOT# L84562, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID (B)(4) LOT# V110880 SERIAL# IMPLANTED: (B)(6) 2008 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID (B)(4) LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2008 EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID (B)(4) LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2008 EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID (B)(4) LOT# V110880 SERIAL# IMPLANTED: (B)(6)2008 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID (B)(4) LOT# L84562 SERIAL# IMPLANTED: (B)(6) 2001 EXPLANTED: PRODUCT TYPE ACCESSORY IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT WORKING AND THE DEVICE HAD QUIT HOLDING A CHARGE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT WITH THE HEALTHCARE PROFESSIONAL SCHEDULED FOR (B)(6) 2015. THERE WERE NO REPORTED PATIENT SYMPTOMS. NO OUTCOME OR TROUBLESHOOTING/INTERVENTIONS WERE REPORTED FOR THIS EVENT. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT. THE PATIENT铠INDICATIONS FOR USE INCLUDED POST LUMBAR LAMINECTOMY SYNDROME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CONSUMER ON 2017-07-06 THAT THE PREVIOUS STIMULATOR AND LEADS WERE REMOVED BECAUSE OF A LEAD ISSUE WHERE THEY BROKE THE WIRES BY BEING DRAGGED BY A HORSE AND IT QUIT WORKING. THIS REVISION HAD ALREADY OCCURRED ON (B)(6) 2016. THE ISSUE STARTED WELL OVER A YEAR TO A YEAR AND A HALF BEFORE THE REMOVAL OCCURRED (AROUND 2014). IT WAS NOTED THAT EVERYTHING WAS WORKING NOW WITH THE NEW IMPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING THE PATIENT. THE PATIENT'S WEIGHT AT THE TIME OF THE EVENT WAS (B)(6)POUNDS. THE STATUS OF THE INS AND LEAD THAT WERE REMOVED REMAINS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738035 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention