BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2913432 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-00513
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 1, 2011
    Report Date
    July 2, 2018
    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, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3888-56 LOT# V081586, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3888-56 LOT# V091860, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3888-33 LOT# V096187, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED:(B)(6) 2008, PRODUCT TYPE :RECHARGER, PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6)2008, PRODUCT TYPE: PROGRAMMER, PATIENT, PRODUCT ID: 3888-56, LOT# V081586, IMPLANTED: (B)(6)2008, PRODUCT TYPE: LEAD, PRODUCT ID:3888-56, LOT# V091860, IMPLANTED:(B)(6) 2008, PRODUCT TYPE: LEAD, PRODUCT ID: 3888-33, LOT# V096187, IMPLANTED: (B)(6)2008, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3888-56 LOT# V081586 IMPLANTED: (B)(6)2008 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3888-56 LOT# V091860 IMPLANTED: (B)(6)2008 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3708220 LOT# (B)(4) IMPLANTED: (B)(6)2008 EXPLANTED: PRODUCT TYPE EXTENSION IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2011, THE PATIENT'S DEVICE, WHICH WAS ORIGINALLY IMPLANTED UNDER THE PATIENT'S LEFT ARM/SIDE, WAS SURGICALLY MOVED DOWN TO THE PATIENT'S LEFT LOWER BACK, UNDER HIS BELT LINE, AND THE LEADS WERE RE-ROUTED. THE REPORTER INDICATED THAT THE DEVICE HAD STARTED CAUSING "TOO MUCH PAIN" AND THE PATIENT WAS LOSING THE USE OF HIS LEFT ARM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER 2018-05-29 CONCERNING PATIENT WITH IMPLANTABLE NEUROSTIMULATOR (INS) FOR FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT THE PATIENT'S LEAD AND EXTENSION WERE MOVED TO A DIFFERENT AREA BUT ARE STILL ACTIVE. NO FURTHER INFORMATION WAS PROVIDER. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP). IT WAS REPORTED THAT PATIENT LOST THE ABILITY TO TURN ON THE STIMULATION IN THE POSTERIOR MID THORACIC QUAD LEADS WITH FINDINGS OF HIGH IMPEDANCE. PATIENT WENT THROUGH OPERATIVE PROCEDURE. THORACIC SPINE ANATOMY WAS VISUALIZED WITH FINDING OF THE LEFT QUAD AND MID THORACIC LEAD DAMAGED ALONG WITH THE EXTENSION LEAD. IT WAS DECIDED AT THIS TIME TO PLACE A NEW LEAD IN THE POSTERIOR MID THORACIC REGION WITH THE NEW EXTENSION TO BE CONNECTED TO THE ORIGINAL BATTERY. HCP HAD DISCUSSED WITH THE PATIENT PRIOR TO SURGERY THAT IF HCP WERE TO FIND ANY DAMAGED LEADS IT WAS DECIDED TO LEAVE DAMAGED LEADS IN PLACE TO DECREASE THE SURGICAL PAIN. THE LEADS WERE THEN CONNECTED TO THE EXTENSION AND THE REP AT THIS TIME INTERROGATED THE LEAD. PATIENT FELT THE SENSATION IN BILATERAL SIDE OF THE POSTERIOR SCALP AND MID THORACIC PARASPINAL AREA. AFTER INTERROGATING THE LEAD THROUGH THE EXTENSION LINE. PATIENT FELT THE HEADACHE AND MID THORACIC PARASPINAL PAIN DECREASE SIGNIFICANTL Y WITH THE ADJUSTMENT AND PROGRAMMING. PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATION WAS NOTED. IN THE RECOVERY PATIENT'S LEADS WAS PROGRAMMER FOR OPTIMAL COVERAGE FOR HEADACHE AND MID THORACIC BACK PAIN WITH >80 % RELIEF OF PAIN. IN 1 WEEK PATIENT WAS TO FOLLOW UP FOR EVALUATION OF THE PERIPHERAL NERVE STIMULATOR IMPLANT AND SURGICAL SITE. CONSIDERING THE PERIPHERAL NERVE STIMULATOR TRIAL THEY HAD PLACE 4 LEADS WITH 80% OF PAIN RELIEF AND ALMOST COMPLETE RELIEF OF HEADACHE PAIN THEY DECIDED TO GO AHEAD AND PLACE AGAIN A TOTAL OF 4 LEADS TO HAVE OPTIMAL RELIEF COVERAGE TO ACHIEVE AGAIN 80% RELIEF. NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21532 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention