BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2925085 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00817
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 8, 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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: THE BATTERY HAD A REDUCED CAPACITY DUE TO OVERDISCHARGE. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS, THE TOTAL RECHARGE COUNT WAS 9. THE LAST RECORDED RECHARGE SESSION DONE WHILE THE DEVICE WAS IMPLANTED WAS ON 2012. THE DEVICE WAS RECHARGED FOR 2 HOURS AND 25 MINUTES. THE BATTERY CHARGED FROM 3.830V TO 3.935V. THE BATTERY DISCHARGED TO THE LOCK MODE ON (B)(6) 2012. THE COUPLING RECORDS OF THE LAST 5 PATIENT RECHARGE SESSIONS WERE AT 75% OR LESS. FINAL DEVICE ANALYSIS OF THE LEAD REVEALED THE FOLLOWING: NO SIGNIFICANT ANOMALY FOUND. THE LEAD BODY WAS CUT THROUGH OR SEGMENTED. FINAL DEVICE ANALYSIS OF THE EXTENSION REVEALED THE FOLLOWING: NO SIGNIFICANT ANOMALY FOUND. THE EXTENSION BODY WAS CUT THROUGH OR SEGMENTED. FINAL DEVICE ANALYSIS OF THE ADAPTER REVEALED THE FOLLOWING: NO ANOMALY FOUND. FINAL DEVICE ANALYSIS OF THE PLUG REVEALED THE FOLLOWING: NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7496-51 LOT# SERIAL# (B)(4), IMPLANTED: 1993 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 64001 LOT# UNKNOWN, PRODUCT TYPE ADAPTER PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3586 LOT# SERIAL# (B)(4), IMPLANTED: 1993 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3550-29 LOT# UNKNOWN, 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

    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 NO STIMULATION SENSATION. THE FIRST OVERDISCHARGE WAS CONFIRMED AND A TRICKLE CHARGE WAS PERFORMED WHICH CLEARED THE OVERDISCHARGE. IT WAS NOTED THAT PATIENT NON-COMPLIANCE WAS THE REASON FOR THE OVERDISCHARGE. IMPEDANCES WERE CHECKED AND THEY WERE ALL WITHIN NORMAL RANGE. HOWEVER, THAT WAS ALL THAT COULD BE DONE AT THE TIME AS THE PATIENT HAD TO CHARGE UP THE BATTERY SOME MORE. IT WAS FURTHER REPORTED THAT A WEEK LATER, THE PATIENT WAS SEEN BY A MEDTRONIC REPRESENTATIVE. IT WAS INDICATED THAT IMPEDANCES WERE GOOD AT THE TIME, BUT THE PATIENT COULD NOT FEEL STIMULATION. EXTENSIVE REPROGRAMMING WAS ATTEMPTED WITH NO LUCK IN GETTING THE PATIENT TO FEEL STIMULATION. ATTEMPTS WERE MADE TO PALPATE THE SYSTEM WITH NO LUCK EITHER ELICITING ANY RESPONSE. THE REPORTER INDICATED THAT THE PATIENT HADN'T HAD FUNCTIONAL STIMULATION SINCE THE END OF APRIL WHEN HER IMPLANTABLE NEUROSTIMULATOR WAS UPGRADED TO A SENSOR. THE PATIENT BELIEVED THAT EVEN BEFORE REPLACEMENT SHE THOUGHT SHE HAD SOME INTERMITTENT STIMULATION AND HAD ONE BURST OF STIMULATION IN A CERTAIN POSITION. POST-IMPLANT IMPEDANCES WERE NOTED TO HAVE BEEN FINE. IMPEDANCE RESULTS AT 3.0V WERE AS FOLLOWS: 0,1 = 423 OHMS; 0,2 = 563 OHMS; 0,3 = 3226 OHMS; 2,3 = 3448 OHMS WHEREAS "DEFAULT" IMPEDANCES WERE REPORTED AS FOLLOW: 0,1 = 571 OHMS; 0,2 = 1497 OHMS; 0,3 = 3608 OHMS. HIGHER AMPLITUDE IMPEDANCE TEST HAD THE FOLLOWING RESULTS: 0,1 = 423 OHMS; 0, 2 = 292 OHMS; 0,3 = 2212 OHMS. IT WAS NOTED THAT THE PATIENT WAS USING ELECTRODE #3 ON THE DAY OF THE REPORT. THE REPORTER INDICATED THAT THE PATIENT WAS GOING TO FOLLOW-UP WITH HER HEALTHCARE PROVIDER (HCP). APPROXIMATELY 6 WEEKS AFTER THE LAST REPORT, IT WAS REPORTED THAT THE PATIENT'S ENTIRE SYSTEM WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING NO STIMULATION SENSATION AS WELL AS HIGH IMPEDANCES. ADDITIONALLY, THE PATIENT DESIRED TO HAVE A NON-RECHARGEABLE DEVICE. AN ENTIRE NEW SYSTEM WAS IMPLANTED. PATIENT INJURY OF INCISIONS WAS NOTED. THE PATIENT RECOVERED WITH SEQUELA FROM SURGERY, AND HAD GREAT STIMULATION AND COVERAGE POST-REVISION. EIGHT DAYS AFTER THE LAST REPORT, FOLLOW-UP INFORMATION FROM THE PATIENT'S HCP INDICATED THAT THE CAUSE OF THE EVENT WAS NO STIMULATION. THERE WAS NO ABNORMAL IMPEDANCE MEASUREMENTS REPORTED. AN X-RAY WAS TAKEN ON (B)(6) 2012 AND THE RESULTS WERE NEGATIVE. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31296 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