BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3901131 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12246
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    September 20, 2013
    Report Date
    May 29, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3587A, LOT# L34759, IMPLANTED: (B)(6) 1995, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (B)(4) FOUND NO SIGNIFICANT ANOMALY. IT WAS REPORTED THAT THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE.

    Additional Manufacturer Narrative · 1

    (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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THEY WERE WAITING FOR A REPLACEMENT DATE DUE TO THE PATIENT¿S INSURANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS ALSO REPORTED THAT THE PATIENT HAD FALLEN BACK ON (B)(6) 2013 AND SINCE THEN THEY HAD EXPERIENCED A SURGING SENSATION WHEN THEY WOULD LIE DOWN OR TWISTING WHEN THEY WERE UPRIGHT. IT WAS NOTED THAT THAT WHEN THEY WERE "STRAIGHT" UPRIGHT THERE WAS NO SURGING. THIS ISSUE WAS REPORTED AS A SUDDEN CHANGE. THE SURGING SENSATION WAS DESCRIBED AS STARTING IN THE PATIENT¿S THORACIC AREA AND RADIATED DOWN TO BOTH LEGS AND FEET. IMPEDANCE TESTING ON THE INS CONDUCTED AT 0.7 VOLTS IN THE PATIENT IN THE UPRIGHT POSITION SHOWED VALUES IN THE NORMAL RANGE. BUT WHEN THE IMPEDANCES WERE TESTED WITH THE PATIENT LYING DOWN, ALL VALUES WERE >10,000 OHMS. IN ADDITION, IT WAS NOTED THAT X-RAYS HAD BEEN DONE (RESULTS NOT REPORTED). IT WAS REPORTED THAT THE PATIENT¿S WAS HAVING A SURGICAL CONSULT TODAY. THE PHYSICIAN HAD DECIDED TO REPLACE THE ¿ENTIRE¿ LEAD AND EXTENSION COMPONENTS BUT THERE WAS CURRENTLY NO APPOINTMENT SCHEDULED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD UNPLEASANT STIMULATION INTERMITTENTLY SINCE FALL. THE PATIENT HAD THEIR ENTIRE SYSTEM REPLACED. THE PATIENT WAS NOT PART OF A CLINICAL STUDY. THE DEVICE WAS RETURNED AND ANALYSIS WAS REQUESTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S DEVICE WAS EXPLANTED (B)(6) 2014. THE PATIENT HAD A POST-OPERATIVE APPOINTMENT (B)(6) 2014, AND THE PATIENT'S OUTCOME WAS NOT KNOWN AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THE ZERO CONTACT WAS FOUND TO BE GREATER THAN 10000 OHMS. POST-OPERATION PROGRAMMING HAD BEEN UTILIZING ZERO CONTACT. THE PATIENT'S STIMULATION HAD STOPPED. THE DAY OF THE POST-OPERATION APPOINTMENT THE PATIENT WAS REPROGRAMMED FOR APPROPRIATE COVERAGE OF PAIN. THREE DAYS LATER THE PATIENT COMPLAINED THEIR STIMULATION STOPPED AGAIN. THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH PHYSICIAN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378950 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 00048 YR Required Intervention