EXTERNAL NEUROSTIMULATOR
Report
- Report Number
- 2182207-2022-00047
- Event Type
- Malfunction
- Date Received
- January 11, 2022
- Date of Event
- December 16, 2021
- Report Date
- July 8, 2022
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 309201, LOT# 60308595, PRODUCT TYPE: SCREENING DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CONTINUATION OF D10: PRODUCT ID 309201 LOT# 60308595 SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE SCREENING DEVICE PRODUCT ID 041839 LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE ACCESSORY 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.
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.
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE HCP DURING THE PNE THE DOC PLACED THE 5 INCH NEEDLE AND WHEN HE WENT TO PUT THE LEAD THROUGH THE LEAD BUCKLED AND WOULD NOT PASS THROUGH THE NEEDLE, THE TIP OF THE LEAD WAS BENT AND HE COULD NOT FIX IT. HE THEN TOOK OUT THE LEAD AND PASSED THE NEEDLE INTRODUCER THROUGH TO MAKE SURE THERE WAS NOTHING BLOCKING THE INSIDE OF THE NEEDLE. THIS PASSED WITH NO PROBLEM. HCP TRIED AGAIN WITH A NEW LEAD AND THE SAME THING HAPPENED AGAIN. THE LEAD MET RESISTANCE AND HE COULD NOT PASS IT THROUGH. HCP THEN TRIED A THIRD TIME WITH ANOTHER NEW LEAD AND THE SAME THING HAPPENED AGAIN. FINALLY HCP PUT A NEW 5 INCH NEEDLE ON THE OTHER SIDE AND THE LEAD PASSED ON THAT SIDE WITH NO ISSUE. LEAVING US TO BELIEVE THERE WAS SOME ISSUE WITH THE FIRST NEEDLE. SO WE THEN OPENED ANOTHER 5 INCH NEEDLE AND WENT BACK TO THE FIRST SIDE (THE PATIENT'S RIGHT SIDE) AND PLACED THE NEW NEEDLE. THIS TIME THE LEAD PASSED WITH NO ISSUE. DR. TRIED TO PUT THE INTRODUCER THROUGH THE NEEDLE TO MAKE SURE THERE WAS NO BLOCKAGE, HE WAS ABLE TO DO THIS, BUT STILL THE LEAD WOULD NOT PASS. HCP ALSO TRIED TO FIX THE LEAD WHEN IT GOT BENT AND THEY COULD NOT FIX IT. NO FURTHER COMPLICATIONS WERE REPORTED AT THIS TIME.
ANALYSIS IDENTIFIED THE {X} ELECTRODE AT THE DISTAL END OF THE LEAD WAS BENT.
ADDITIONAL INFORMATION RECEIVED FROM REP. THEY REPORTED THE LEAD /NEEDLE WERE RECEIVED AND THEY WERE SENT BACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 687256 | EXTERNAL NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON | EZW | MEDTRONIC NEUROMODULATION | NEU_ENS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female |