BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2972001 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02940
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 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 ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED "NO ANOMALY." IT WAS FURTHER STATED THAT "ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS, THE TOTAL RECHARGE COUNT IS 54. THE LAST RECORDED RECHARGE SESSION DONE WHILE THE DEVICE WAS IMPLANTED WAS ON (B)(6) 2013 FOR 7 SECONDS. PRIOR RECHARGE ON (B)(6) 2013 LASTED 1HOUR AND 32 MINUTES; THE BATTERY CHARGED FROM 3.840V TO 3.865V. THE BATTERY HAS NEVER DISCHARGED TO THE LOCK MODE. THE COUPLING RECORD OF THE LAST 5 PATIENT RECHARGE SESSIONS HAS 5 AT 25% AND 1 AT 0%. TESTING OF THE RECHARGE FUNCTION OF THIS INS FOUND IT TO BE FUNCTIONING NORMALLY. THE INS WAS RECHARGED AT BODY TEMPERATURE WITH APPROXIMATELY 1CM OF SPACE BETWEEN THE INS AND CHARGER ANTENNA. THE CHARGE TIME WAS 4HRS 18 MIN. THE INS CHARGED FROM 3.545V TO 4.020V WITH 100% COUPLING."

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3776-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3776-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED DUE TO COMMUNICATION/TELEMETRY ISSUE AND COUPLING ISSUES. MULTIPLE ATTEMPTS WERE MADE TO INCREASE COUPLING FOR CHARGING OVER A PERIOD OF SEVERAL MONTHS. THE PATIENT TYPICALLY OBTAINED NO MORE THAN 2 BARS OF COUPLING STRENGTH AND CHARGING TOOK 8 HOURS TO COMPLETE. IT WAS STATED THAT THE PATIENT WAS ONCE OR TWICE ABLE TO GET 3-4 BARS THAT LASTED A FEW SECONDS ONLY. A DIFFERENT CHARGER WAS UTILIZED WITH IDENTICAL RESULTS. POCKET DEPTH WAS MEASURED AT LESS THAN ONE CENTIMETER. PATIENT STATUS AT THE TIME OF THIS REPORT WAS NOTED AS ALIVE WITH NO INJURY/NO ADVERSE EVENT. THE REPLACEMENT WAS PERFORMED AT THE DISCRETION OF THE SURGEON. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. THREE DAYS LATER NOT NORMAL BATTERY DEPLETION WAS ALSO MENTIONED. NO DEATH AND NO INJURY WERE REPORTED. THE PATIENT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76903 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