BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3998563 · Received August 11, 2014

    Report

    Report Number
    3004209178-2014-15064
    Event Type
    Injury
    Date Received
    August 11, 2014
    Report Date
    July 17, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION: PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3987A, LOT# N183268, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4). ANALYSIS RESULTS FOR THE DEVICE (SERIAL # (B)(4)) FOUND THAT THERE WAS NO SIGNIFICANT ANOMALY. IT WAS ALSO NOTED THAT THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS RECEIVED WITH NO TELEMETRY. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS AFTER PMR RECOVERY, THE TOTAL RECHARGE COUNT WAS 57. THE OLDEST RECHARGE RECORD WAS DATED (B)(6) 2000 INDICATING A PRIOR RECOVERY FROM A LOW VOLTAGE POR AND SUBSEQUENT CLOCK/DATE RESET. THE TWO FOLLOWING RECORDS WERE DATED (B)(6) 2000. THE NEXT MOST RECENT RECORD WAS DATED (B)(6) 2000 INDICATING ANOTHER RECOVERY FROM A LOW VOLTAGE POR AND CLOCK/DATE RESET. THE LAST RECHARGE RECORD PRIOR TO EXPLANT WAS APPARENTLY 25 DAYS LATER WITH A DATE OF (B)(6) 2000. THE DEVICE WAS RECHARGED FOR 5 HOURS AND 14 MINUTES. THE BATTERY CHARGED FROM 3.580V TO 4.030V. ALL TEN THERAPY AVAILABLE RECORDS HAD DATES WITH THE YEAR ¿2000¿. THERAPY WAS LAST ENABLED ON (B)(6) 2012 AND LAST DISABLED ON (B)(6) 2012. IN THE RPA LAB A NORMAL RECHARGE WAS STARTED MANUALLY AFTER A PHYSICIAN MODE RECHARGE AT BODY TEMPERATURE WITH A 1CM SPACER BETWEEN THE INS AND RECHARGE ANTENNA. THE RECHARGER HAD FULL COUPLING AND THE INS RECHARGED FOR 6 HOURS AND 56 MINUTES FROM 1.980V TO 3.960V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ONLY ABLE TO CHARGE ONE OF THEIR THREE IMPLANTABLE NEUROSTIMULATORS (INS). THE PATIENT STATED THAT THEY HAD ONE INS IN THEIR ABDOMEN, ONE ON THEIR LEFT HIP AND ONE ON THEIR RIGHT SIDE. THE PATIENT NOTED THAT THE ONE ON THE RIGHT SIDE WAS THE ONE THAT THEY COULD CHARGE. IT WAS NOTED THAT AN INS OVERDISCHARGE WAS SUSPECTED. THE LAST SUCCESSFUL RECHARGE SESSION AND THE LAST TIME ANY STIMULATION WAS FELT WAS A ¿COUPLE MONTHS¿ PRIOR TO REPORT. THE PATIENT STATED THAT THE REPOSITION ANTENNA SCREEN CAME UP. THE PATIENT NOTED THAT THEY HAD ATTEMPTED TO USE THE ANTENNA LOCATE FEATURE THREE TO SIX TIMES. THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROFESSIONAL (HCP). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS OVER-DISCHARGED AND UNRECOVERABLE. IT WAS ALSO NOTED THAT THE OVERDISCHARGE WAS UNABLE TO BE RECOVERED AND WAS REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY FOLLOWING THEIR REPLACEMENT PROCEDURE AND THEY WERE SCHEDULED TO BE SEEN FOR FOLLOW UP ON (B)(6) 2014. PLEASE REFER TO MANUFACTURES REPORT # 3004209178-2014-15061 FOR ADDITIONAL INFORMATION ON A RELATED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476332 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 00066 YR Required Intervention