BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2770870 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08847
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 7, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_STYLET_ACC LOT#, EXPLANTED: 2013 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 3 778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37081 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37081 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION. FINAL DEVICE ANALYSIS OF THE LEAD L/N (B)(4), REVEALED THE FOLLOWING: CONDUCTORS # 0-7 BROKE 16.8 CM FROM DISTAL END. FINAL DEVICE ANALYSIS OF THE LEAD L/N (B)(4), REVEALED THE FOLLOWING: CONDUCTOR #7 IS BROKEN AT THE WELD SITE. FINAL DEVICE ANALYSIS OF THE STYLET REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37081, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37081, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING 'POSITIONAL JOLTING' OR A SURGING SENSATION. IT WAS NOTED THAT THE PATIENT NEEDED TO LIE ON HER SIDE FOR THE DEVICE TO WORK PROPERLY. THIS PROBLEM HAD OCCURRED SINCE IMPLANT. THE JOLTING WAS AT THE THERAPY SITE. THE PATIENT HAD GOOD COVERAGE OF THE PAIN AREA WHEN IT WAS WORKING. NO TRAUMA OR FALLS WERE REPORTED. HIGH IMPEDANCES WERE REPORTED. IMPEDANCES OF OVER 20,000 OHMS WERE SEEN ON SEVERAL ELECTRODES WHEN THE VOLTAGE WAS 1.5 V. DIFFERENT REFERENCE ELECTRODES AND PAIRS WERE TRIED. THE LEAD WITH CONTACTS 0-7 REPEATEDLY HAD HIGH IMPEDANCES. THE LEAD WITH CONTACTS 8-15 HAD CONSISTENTLY HIGH IMPEDANCES ONLY ON CONTACT 15. IT WAS NOTED THAT THE LEAD WITH CONTACTS 0-7 WAS NOT USED IN PROGRAMMING. IT WAS UNKNOWN IF HIGH IMPEDANCES HAD BEEN A PROBLEM SINCE IMPLANT. ADDITIONAL INFORMATION REPORTED THAT THE HIGH IMPEDANCES DID NOT RESOLVE. AN X-RAY WAS TAKEN AT THAT SAME APPOINTMENT, BUT THE RESULTS WERE UNKNOWN. AFTER REPROGRAMMING THE PATIENT'S DEVICE, THE PATIENT WAS GETTING FULL COVERAGE AND HAD NO POSITIONAL JOLTS AT THAT TIME. IT WAS THOUGHT THAT THE REPROGRAMMING RESOLVED THE POSITIONAL JOLTS AND THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO LEADS WERE BROKEN/FRACTURED. THE IMPEDANCES WERE GREATER THAN 40,000 OHMS ON 0-7 ELECTRODES AND THERE WAS A LOSS OF STIMULATION. PATIENT STATED THAT COVERAGE WAS "NOT AS IT USED TO BE." IT WAS REPORTED THAT THE PATIENT HAD LESS THAN 50% RELIEF FROM HER RIGHT KNEE TO ANKLE. BOTH LEADS WERE REMOVED AND REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ONE LEAD WAS FUNCTIONING (ELECTRODES 8-15) AND THEY WERE USING JUST THAT LEAD FOR PROGRAMMING. THE REPORTER STATED THAT THE LEAD WITH ELECTRODES 0-7 HAD HIGH IMPEDANCES. IT WAS REPORTED THAT THE PATIENT WAS GETTING ADEQUATE COVERAGE WITH JUST ONE LEAD, AND THE HEALTH CARE PROVIDER WAS "OK" WITH USING JUST ONE LEAD. THE REPORTER STATED THAT THERE WERE NO PLANS FOR A REVISION UNLESS THE PATIENT DECIDES THE COVERAGE IS NOT ENOUGH AND THEY WANT A REVISION, THEN THE DOCTOR WOULD DO REVISION SURGERY. IT WAS NOTED THAT CURRENTLY THE PATIENT WAS FINE WITH THE COVERAGE SHE HAD. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention