BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3050718 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05874
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 27, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF NEUROSTIMULATOR MODEL 37711HJ SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES. ANALYSIS OF LEAD MODEL 3587A SHOWED NO SIGNIFICANT ANOMALIES. ANALYSIS OF EXTENSION MODEL 37083 SERIAL UNKNOWN SHOWED NO SIGNIFICANT ANOMALIES. ANALYSIS OF PLUG ACCESSORY MODEL 3550-29 SHOWED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    (B)(4)ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3587A, IMPLANTED: (B)(6) 1998, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 37083, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S SYSTEM "NO LONG PROVIDED STIMULATION" SO THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR). DURING SURGERY IT WAS DISCOVERED THAT THE LEAD HAD BEEN SEVERED DUE TO BONE THAT HAD GROWN OVER THE TAIL OF THE LEAD AT THE POINT THAT WAS CLOSEST TO THE PADDLE. IT WAS NOTED THAT THE LEAD WAS IMPLANTED IN 1998. IT WAS STATED THAT THE EXTENSION HAD BEEN DAMAGED AS WELL. THE SURGEON REPLACED THE LEAD AND THE EXTENSION. WHEN IT WAS CONNECTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS) THE IMPEDANCES WERE HIGH. A NEW INS WAS USED AND THE IMPEDANCES WERE "NORMAL". IT WAS REPORTED THAT THERE WAS NO PATIENT DEATH OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150238 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711HJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention