BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 9677064 · Received February 6, 2020

    Report

    Report Number
    3004209178-2020-02730
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    October 1, 2018
    Report Date
    June 30, 2020
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS #253993950:ANALYSIS INFORMATION -- 2020-06-05 10:31:15 CST PLI# 10 PRODUCT ID# 37712 BELOW IS UNEDITED, SYSTEM GENERATED TEXT BASED ON THE ANALYSIS FINDING CODE(S). THE RETURNED DEVICE WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE BUT IS NOT LIMITED TO VISUAL INSPECTION, OUTPUT AND TELEMETRY TESTING, AND FUNCTIONAL TESTING. ANALYSIS DETERMINED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS FUNCTIONING WITHIN SPECIFICATIONS BUT HAS REDUCED CAPACITY DUE TO {X} OVERDISCHARGE{S}. CONTINUATION OF D11: PRODUCT ID 3778-60 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) EXPLANTED: (B)(6) PRODUCT TYPE LEAD PRODUCT ID 3778-60 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) EXPLANTED: (B)(6) PRODUCT TYPE LEAD MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS #253993950:ANALYSIS INFORMATION -- 2020-06-05 10:31:15 CST PLI# 10 PRODUCT ID# 37712 BELOW IS UNEDITED, SYSTEM GENERATED TEXT BASED ON THE ANALYSIS FINDING CODE(S). THE RETURNED DEVICE WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE BUT IS NOT LIMITED TO VISUAL INSPECTION, OUTPUT AND TELEMETRY TESTING, AND FUNCTIONAL TESTING. ANALYSIS DETERMINED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS FUNCTIONING WITHIN SPECIFICATIONS BUT HAS REDUCED CAPACITY DUE TO {X} OVERDISCHARGE{S}. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    METHOD, RESULT AND CONCLUSION EVAL CODES ADDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL CORD STIMULATION - NON-MALIGNANT PAIN/ POST LUMBAR LAMINECTOMY SYNDROME. IT WAS REPORTED THAT THE INS WAS OVERDISCHARGED AND PATIENT WAS NOT ABLE TO RECHARGE HER IMPLANT OVER A YEAR AGO. PATIENT LAST ATTEMPTED TO RECHARGE IN (B)(6) 2018 BUT COULD NOT. THE MANUFACTURER'S REPRESENTATIVE (REP) REPORTED THAT THE PATIENT CALLED HER LAST FRIDAY. THE REP GOT DONE WITH THE FIRST PHYSICIAN MODE RECHARGE (PMR) AND GOT ERROR CODE, 1861662. IT WAS REVIEWED WITH THE REP THAT THE CODE HAS BEEN SEEN BEFORE HOWEVER UNABLE TO EXPLAIN THE MEANING OF CODE. IT WAS REVIEWED THAT ANOTHER PMR WOULD BE NEEDED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THE REP WAS UNSUCCESSFUL IN GETTING THE BATTERY POWERED BACK UP. PATIENT TO MEET WITH THE HCP ON (B)(6) TO DISCUSS REPLACEMENT. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REP FOLLOWED UP WITH THE HCP OFFICE. THE PATIENT WAS BEING SCHEDULED FOR A BATTERY REPLACEMENT AND THEY WERE IN THE MIDST OF GETTING AUTHORIZATION FOR THE SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT GOT GREAT RELIEF FROM NEUROSTIMULATOR DURING USAGE. BATTERY DIED. PATIENT REPORTED THAT CHARGING WAS UPWARDS OF 4 HOURS WHEN SYSTEM WAS FUNCTIONING. PATIENT'S DEVICE WAS EXPLANTED AND GIVEN NEW, MRI COMPATIBLE SYSTEM. THERE WERE NO KNOWN CAUSES. NO DIAGNOSTICS/TROUBLESHOOTING WAS PERFORMED. THE ISSUE WAS RESOLVED. HCP HAD NO FURTHER INFORMATION. PATIENT'S WEIGHT WAS ASKED BUT UNKNOWN. THE DEVICE WAS RETURNED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140179 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 52 YR Required Intervention "SEE H10...."