BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 16538571 · Received March 14, 2023

    Report

    Report Number
    3004209178-2023-03476
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    December 29, 2022
    Report Date
    March 27, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315474
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: ADDITION OF PMA P840001. 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

    CONTINUATION OF D10: PRODUCT ID 977A260 LOT# SERIAL# VA2PKM1041 IMPLANTED: (B)(6) 2022 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 977A260 LOT# SERIAL#(B)(4), IMPLANTED: (B)(6) 2022 EXPLANTED: PRODUCT TYPE LEAD INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A260, SERIAL/LOT #: (B)(4), UBD: 21-OCT-2026, UDI#:(B)(4); PRODUCT ID: 977A260, SERIAL/LOT #: (B)(4), UBD: 21-OCT-2026, UDI#: (B)(4). 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.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. THEY HCP REACHED OUT TO THE MANUFACTURING REPRESENTATIVE (REP) AND STATED THAT PATIENT SAYS HER DEVICE HAS NOT PROVIDED ANY RELIEF.  APPARENTLY TRIAL WAS EXECUTED FOR INTERCOSTAL NEURALGIA AND PANCREATITIS. POSSIBLY SOME OF THE CHILD PATIENT FELT LIKE SHE HAD NEARLY 100% RELIEF ON HER INTERCOSTAL NEURALGIA, BUT AS HER PANCREATITIS IS EPISODIC, SHE DID NOT EXPERIENCE AN EPISODE WITH WHICH SHE COULD EVALUATE TREATMENT THAT ISSUE. PATIENT WAS UNCERTAIN AT LEAD PULL AND TOLD PHYSICIANS THAT SHE WOULD THINK ABOUT IT AND REPORT. PATIENT FOUND THAT SHE MISSED THE RELIEF SHE WAS RECEIVING FOR THE INTERCOSTAL NEURALGIA AND DECIDED TO PROCEED. PATIENT WAS IMPLANTED AT THE END OF DECEMBER, 2022 AND DEVICE WAS NOT ACTIVATED TO ONE WEEK. AT THE POSTOP FOLLOW UP. PATIENT INFORMED THE REP TODAY THAT SHE HAD PAIN FROM HER SPINAL INCISION, CEPHALAD. PATIENT WAS PROGRAMMED AT THAT TIME AND WENT ON HER WAY. TODAY PHYSICIAN SEES PATIENT AND AS SHE HAS BEEN HOSPITALIZED WITH SEVERAL BOUTS OF PANCREATITIS, WE CONCLUDED THAT SHE IS NOT RECEIVING ANY PAIN RELIEF AS SHE HAS HAD SEVERAL EPISODES, AND THEN HOSPITALIZED FOR THOSE EPISODES. ALSO, SHE COMMENTS TODAY THAT SHE DOES NOT HAVE ANY RELIEF FOR HER INTERCOSTAL NEURALGIA. PATIENT HAS BEEN SEEN AND HAD ATTEMPT AT REPROGRAMMING, BUT APPARENTLY HAS NOT PROVIDED ANY BENEFIT. THE REP WILL SEE PATIENT NEXT WEEK, WE WILL GET A F LUOROSCOPY PICTURE AND SEE IF THEY CAN UNDERSTAND WHAT ISSUE MIGHT BE FROM THAT IMAGE. THEY WILL ALSO ATTEMPT TO REPROGRAM HER, NOT SO MUCH FOR HER PANCREATITIS, BUT AT LEAST BRING HER SOME OF THE RELIEF SHE EXPERIENCED IN THE TRIAL FOR INTERCOSTAL NEURALGIA. WILL ATTEMPT TO MAKE USE OF LEAD FOR PANCREATITIS TO SEE IF WE CAN AVOID SOME OF THESE DEBILITATING EPISODES. THE REP INDICATED THAT THEY NEVER PROGRAMED THE PATIENT FOR THIS INDICATION. 2023-02-22 MPXR 1030799/UPDATES: ADDITIONAL INFORMATION FROM THE REP INDICATED THAT THEY SAW THE PATIENT AND REPROGRAMMED HER. HER LEADS HAVE MOVED CEPHALAD A BIT. THE REP REPROGRAMED HER WITH A COMBINATION THERAPY TO TRY AND TAKE CARE OF HER RIGHT RIB, PERIPHERAL NEUROPATHY, AND SOME PAIN IN HER BACK. THE REP GAVE HER THREE GROUPS. SHE WILL EVALUATE EACH GROUP 4 DAYS ON AND ONE DAY OFF AND GET BACK TO THE REP IF THERE IS SOME BENEFIT AND WHICH GROUP WAS BEST. THE HCP TOOK FLUOROSCOPIC PICTURES IN THE HCP OFFICE WHICH NOTED THE LEADS HAD MOVED TO T4/T5 AND ALSO THAT THEY WERE PERFECTLY DORSAL EXCEPT FOR THE CAUDAL LEAD WHICH WAS MEANT TO PICK UP THE NEURALGIA IN THE RIGHT RIB AREA, SO TIP SLIGHTLY TO THE RIGHT. THE HCP WAS NOT ABLE TO SPECULATE AS TO SENSITIVITY IN SPINE AREA BETWEEN SHOULDER BLADES. ¿KNOT¿ IN MID THORACIC AREA INEXPLICABLE, BUT DOESN¿T SEEM TO BE AN ANATOMICAL REASON DEVICE CAUSING ¿KNOT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015427 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97716 00763000315474

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female "SEE H10...."