BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4178120 · Received October 16, 2014

    Report

    Report Number
    3004209178-2014-19816
    Event Type
    Injury
    Date Received
    October 16, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-33, LOT# V643872, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-56, LOT# VA00DGT, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3888-33, LOT# V993052, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-56, LOT# V829963, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-56, LOT# VA00DGT, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-56, LOT# V829963, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS DETERMINED NO SIGNIFICANT ANOMALY. THE INS BATTERY HAD A REDUCED CAPACITY DUE TO OVERDISCHARGE. 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 WAS 17. THE LAST RECORDED RECHARGE SESSION DONE WHILE THE DEVICE WAS IMPLANTED WAS ON (B)(6) 2014. THE DEVICE WAS RECHARGED FOR 1 HOUR AND 18 MINUTES. THE BATTERY CHARGED FROM 3.735V TO 3.845V. THE PARAMETER TREND DIAGNOSTIC SECTION OF THE TRACE REPORT SHOWS PATIENT USAGE AFTER THIS RECHARGE SESSION. THE BATTERY DISCHARGED TO THE LOCK MODE ON (B)(6) 2014; THERE ARE 3 TOTAL LOCK COUNTS. ANALYSIS OF THE LEAD, LOT # VA00DGT, DETERMINED NO SIGNIFICANT ANOMALY. THE BODY OF THE LEAD WAS CUT THROUGH OR SEGMENTED. ANALYSIS OF THE LEAD, LOT # V829963, DETERMINED NO SIGNIFICANT ANOMALY. THE BODY OF THE LEAD WAS CUT THROUGH OR SEGMENTED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED CONCLUSION: NO LONGER APPLIES TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A GRADUAL LOSS OF STIMULATION. THE PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF AT THE LEAD LOCATION. THE PHYSICIAN ADVISED REPROGRAMMING THE PATIENT, BUT THE PATIENT WANTED TO PROCEED WITH THE EXPLANT. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658218 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 00039 YR Required Intervention