BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2934366 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01101
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Removal / Correction Number
    Z-0500-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3550-39. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3550-39. PRODUCT TYPE: ACCESSORY. (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. THE DEVICE IS INCLUDED IN THE MEDICAL DEVICE SAFETY ALERT, FOR THE MODEL 3550-39 TITAN ANCHOR DUE TO THE POTENTIAL FOR LEAD MIGRATION AS A RESULT OF INSERT SEPARATION WITHIN THE ANCHOR, PHYSICIAN COMMUNICATION ((B)(6) 2009).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PRODUCT REVEALED THE FOLLOWING: TITAN ANCHOR (1) - NO SIGNIFICANT ANOMALY, THE STIMULATION ANCHOR WAS CUT THROUGH ANALYSIS OF THE PRODUCT REVEALED THE FOLLOWING: TITAN ANCHOR (2) - RELIABILITY NON-CONFORMANCE, THE STIMULATION ANCHOR WAS SEPARATED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE, REMEDIAL ACTION OTHER TEXT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD MIGRATED "UP AND OVER." A LEAD REVISION WAS DONE ON (B)(6) 2013. IT WAS STATED THE "CLAMPS" CAME OUT. AN X-RAY WAS TAKEN IN (B)(6) 2012 TO HELP DIAGNOSE THE ISSUE. IT WAS NOTED THE PATIENT HAD STIMULATION IN THEIR STOMACH; HOWEVER, THE PATIENT STILL EXPERIENCED PAIN IN THEIR LEG AND FEET. FURTHER PROGRAMMING WAS PLANNED FOR (B)(6) 2013. IT WAS FURTHER REPORTED THAT BOTH LEADS WITHIN THE PATIENT'S SYSTEM HAD MIGRATED. IN ADDITION THE "TITAN ANCHOR FOUND TO BE SEPARATED." IT WAS UNCLEAR IF BOTH TITAN ANCHORS IN THE SYSTEM HAD SEPARATED OR JUST ONE. IT WAS INDICATED THAT THE PATIENT WAS DOING "WELL". A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40627 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention