BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3887079 · Received June 20, 2014

    Report

    Report Number
    3004209178-2014-11886
    Event Type
    Injury
    Date Received
    June 20, 2014
    Report Date
    May 30, 2014
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-45, LOT# V814277, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3998, LOT# V855145, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3888-45, LOT# V690039, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. ANALYSIS OF THE LEAD, LOT# V814277, FOUND THAT THE OUTER INSULATION HAD SEPARATED THAT THE PROXIMAL END OF THE BUTT JOINT. ANALYSIS OF THE EXTENSION, SERIAL# (B)(4), FOUND NO ANOMALY. ANALYSIS OF THE EXTENSION, SERIAL# (B)(4), FOUND THAT THE EXTENSION BODY HAD BEEN CUT THROUGH AND THE PRODUCT WAS SEGMENTED. ANALYSIS OF THE LEAD, LOT# V690039, FOUND THAT THE BODY CONDUCTOR HAD BROKEN DUE TO OVERSTRESS DAMAGE.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3888-45, LOT# V814277, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3998, LOT# V855145, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3888-45, LOT# V690039, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE RECEIVED A CALL FROM THE SURGERY SCHEDULER FOR A DOCTOR. THE CALL WAS ABOUT A LEAD REVISION TENTATIVELY PLANNED FOR (B)(6) 2014. THEN THE MANUFACTURER REPRESENTATIVE CALLED THE PATIENT WHO NOTED THAT THEY HAD A TRIAL WITH FAIR RELIEF AND WENT TO IMPLANT. IT WAS NOTED THAT A DIFFERENT DOCTOR IMPLANTED WAS NOT ABLE TO GET THE LEAD IN THE CORRECT POSITION AND HAD NOT HAD GOOD COVERAGE SINCE. IT WAS NOTED THAT THE PATIENT HAD STIMULATION/THERAPY ISSUES DESCRIBED AS THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS ALSO NOTED THAT THE PATIENT HAD LESS THAN 50% THERAPY RELIEF IN THE LOWER BACK AND BILATERAL LEGS. THEN THE MANUFACTURER REPRESENTATIVE SPOKE WITH THE WIFE WHO STATED THAT PATIENT OBTAINED SOME RELIEF BUT HAD TO TURN IT UP ¿SO HIGH¿ THAT IT ¿JUST REPLACED ONE PAIN WITH ANOTHER.¿ IT WAS NOTED THAT DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS NOT PERFORMED BUT WOULD BE PERFORMED IN THE FUTURE. IT WAS NOTED THAT THE EVENT OCCURRED DURING NORMAL USE. IT WAS NOTED THAT PRODUCT STATUS OF THE LEADS WITH LOT NUMBER V814277 AND V855145 WAS IMPLANTED AND REMAINS IN SERVICE. THE PATIENT¿S STATUS WAS ALIVE WITH NO INJURY. IT WAS LATER REPORTED THAT TWO NEW LEADS WERE PLACED IN THE BILATERAL LOWER BACK/UPPER BUTTOCKS. IT WAS ALSO NOTED THAT TWO OTHER NEW LEADS WERE PLACED EPIDURALLY. IT WAS ALSO NOTED THAT LEADS WERE CONNECTED TO NEW EXTENSIONS WHICH WERE CONNECTED TO THE EXISTING IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT ALL IMPEDANCES WERE WITHIN NORMAL LIMITS (WNL). THE LEAD WITH LOT NUMBER V814277 WAS LISTED AS REMOVED (B)(6) 2014. THE LEAD WITH LOT NUMBER V690039 WAS LISTED AS PARTIALLY REMOVED (B)(6) 2014. IT WAS ALSO NOTED THAT THE V690039 DISTAL END WAS LEFT IN PLACE. THE LEAD WITH LOT NUMBER V855145 WAS DESCRIBED AS INACTIVATED (B)(6) 2014 AND LEFT IN THE EPIDURAL SPACE CONNECTED TO THE DISTAL END OF A PARTIALLY REMOVED EXTENSION OF MODEL NUMBER 3708240 (SERIAL NUMBER (B)(4)). HOWEVER, LATER THE MANUFACTURER REPRESENTATIVE LISTED THE EXTENSION WITH MODEL NUMBER 3708240 (SERIAL NUMBER (B)(4)) SIMPLY AS ¿REMOVED¿ (B)(6) 2014 AND NOT PARTIALLY REMOVED. THE EXTENSION WITH NKB012005V WAS LISTED AS REMOVED (B)(6) 2014. IT WAS NOTED THAT THE PROXIMAL 2/3RDS OF EXTENSION 37082-40 WOULD BE RETURNED AS WELL AS THE PROXIMAL 2/3RDS OF 3888-45 LEAD. IT WAS NOTED THAT ONE OTHER LEAD AND EXTENSION WOULD BE RETURNED. IT WAS NOTED THAT NO OTHER ACTIONS WERE NEEDED OR PLANNED. IT WAS NOTED THAT THE PATIENT W AS PLEASED WITH COVERAGE POST-SURGERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT TWO EXTENSIONS AND TWO LEADS WERE EXPLANTED ON (B)(6) 2014. IT WAS STATED THAT THE DEVICES WERE EXPLANTED BECAUSE THE PATIENT HAD INADEQUATE COVERAGE. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED FROM THE PROCEDURE WITHOUT SEQUELA. ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHILE BEING SEEN AT THE POST-OP VISIT, THE PATIENT RECEIVED 'GOOD COVERAGE OF HIS LEFT LEG AND LOWER BACK ON THREE GROUPS.' IT WAS NOTED THAT THE PATIENT HAD 'MUCH IMPROVED RELIEF AND FULL COVERAGE OF PAINFUL AREAS.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363256 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 00050 YR Required Intervention