NIM 4.0 PATIENT INTERFACE
Report
- Report Number
- 1045254-2023-01037
- Event Type
- Malfunction
- Date Received
- December 1, 2023
- Date of Event
- November 2, 2023
- Report Date
- May 9, 2024
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- GWF
- UDI-DI
- 00763000395902
- PMA / PMN Number
- K200759
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H3: ANALYSIS FOR PRODUCT ID: NIM4CPB1, SERIAL NUMBER: (B)(6)UPDATED THE DEVICE HAS WATER/MOISTURE DAMAGE ON THE INSIDE AND THERE IS CORROSION ON THE PRINTED CIRCUIT BOARDS IN VARIOUS PLACES. H6: PREVIOUS FDC CODE D02 NO LONGER APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NIM4CM01, SERIAL/LOT #: (B)(6) , UDI#: (B)(4), IMG CODE G02030; PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6) , UDI#: (B)(4), IMG CODE G02005 ; PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6), UDI#: (B)(4), IMG CODE G02005 ; PRODUCT ID: NIM4CM01, SERIAL/LOT #: (B)(6), UDI#: (B)(4), IMG CODE G02030 ; PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6), UDI#: (B)(4) , IMG CODE G02005. G2: MFG. DATE FOR NIM4CM01, SERIAL/LOT #: (B)(6) IS (B)(6)2022 MFG. DATE FOR PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6) IS 2023-04-27 MFG. DATE FOR PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6) IS 2023-05-16 MFG. DATE FOR PRODUCT ID: NIM4CM01, SERIAL/LOT #: (B)(6) IS (B)(6) 202304-25 MFG. DATE FOR PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6) IS 2023-04-25 H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. FOR NIM4CPB1, SERIAL/LOT #:(B)(6) DEVICE IS NOT YET RETURNED TO MANUFACTURER. H6: CODES FOR PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6) ARE FDM B17, FDR C20 AND FDC D14. 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.
H3: ANALYSIS FOUND NO ANOMALIES. DEVICE WAS RETURNED IN GOOD CONDITION. ANALYSIS FOR PRODUCT ID: NIM4CPB1, SERIAL NUMBER: (B)(6) FOUND THAT -THE PATIENT INTERFACE SOFTWARE HAS VERSION V1.4.3 10/10/2022 (7D16BA54). THE BATTERIES ARE EMPTY AND WILL NOT CHARGE, THE PI POWERS IT SELF OFF. THE PI POWERS ITSELF OFF, CAN'T PERFORM THE TESTS. THE LOWER ENCLOSURE NEEDS TO BE REPLACED BECAUSE IT HAS TWO BROKEN OFF STANDS. IMG CODE G02002 AND G04070 ARE FOR PRODUCT ID: NIM4CPB1, SERIAL NUMBER: (B)(6). H6: PREVIOUS CODES: B17, C20, B21, C21 AND D16 ARE NO LONGER APPLICABLE. C0601 IS FOR PRODUCT ID: NIM4CPB1, SERIAL NUMBER: (B)(6). 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.
IT WAS REPORTED THAT INTRA-OP, THE MEASUREMENTS COULD ONLY BE CARRIED OUT PARTIALLY OR NOT AT ALL. NO PATIENT IMPACT.
IT WAS REPORTED THAT INTRA-OP, THE MEASUREMENTS COULD ONLY BE CARRIED OUT PARTIALLY OR NOT AT ALL. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1399059 | NIM 4.0 PATIENT INTERFACE | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | GWF | MEDTRONIC XOMED INC. | NIM4CPB1 | 226433841 | 00763000395902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | "SEE H10." |