BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3013703 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-04011
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    March 1, 2013
    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 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION . PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID 3550-14, LOT# N320728, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: THE INS WAS RECEIVED WITH NO TELEMETRY. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS AFTER PMR RECOVERY, THE TOTAL RECHARGE COUNT PRIOR TO RECEIPT IN THE ANALYSIS LAB IS 2. THE LAST RECORDED RECHARGE SESSION DONE WHILE THE DEVICE WAS IMPLANTED WAS ON THE DEFAULT DATE (B)(4) 2000. THE BATTERY WAS RECHARGED FOR 38 MINUTES FROM 1.965V TO 3.385V. THE PRIOR CHARGE DATE IS (B)(4) 2012 AND LASTED FOR 6 MINUTES. THE BATTERY LEVEL REMAINED AT 3.460V. THE INS WAS RECHARGED FOR ANALYSIS AT BODY TEMPERATURE. A NORMAL RECHARGE STARTED AUTOMATICALLY AFTER A PHYSICIAN MODE RECHARGE WITH A 1CM SPACER BETWEEN THE INS AND RECHARGE ANTENNA. THE RECHARGER HAD FULL COUPLING AND THE INS RECHARGED FOR 6 HOURS AND 20 MINUTES FROM 2.515V TO 3.940V. CHARGING WAS INTERRUPTED TO OBTAIN THE IR AND TRACE REPORT. CHARGING RESUMED FOR 11 MINUTES BRINGING THE BATTERY VOLTAGE TO 3.945V. BATTERY DISCHARGES RAPIDLY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPORTED TO BE "IN OVERDISCHARGE (OD)". IT WAS FURTHER REPORTED THAT THE OD STATE WAS DUE TO "PATIENT COMPLIANCE". IT WAS NOTED THAT TELEMETRY BETWEEN THE PATIENT'S INS AND THE RECHARGER, PATIENT PROGRAMMER, OR CLINICIAN PROGRAMMER WAS "NOT POSSIBLE". IT WAS FURTHER NOTED THAT THE ANTENNA LOCATE FEATURE "DID NOT RESULT IN POWER ON RESET" AND THE BEST THEY "COULD GET WAS 70". THE PATIENT'S INS WAS ADDITIONALLY REPORTED TO HAVE BEEN "A LITTLE TILTED AS WELL". IT WAS REPORTED THAT A PHYSICIAN MODE RECHARGE WAS UNSUCCESSFULLY ATTEMPTED FOR ONE HOUR. IT WAS NOTED THAT THE PATIENT "OPTED TO DISCONTINUE THE ATTEMPTS". IT WAS ALSO NOTED THAT THIS WAS THE "SECOND EPISODE" OF THE PATIENT'S INS GOING INTO OVERDISCHARGE. IT WAS REPORTED THAT THE PATIENT'S INS WAS EXPLANTED AND REPLACED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115958 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention