INCEPTIV
Report
- Report Number
- 3004209178-2024-14305
- Event Type
- Injury
- Date Received
- July 8, 2024
- Date of Event
- June 27, 2024
- Report Date
- March 4, 2025
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00763000540302
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
CONTINUATION OF D10: PRODUCT ID 3487A LOT# J0220119V SERIAL# IMPLANTED: (B)(6) 2002: PRODUCT TYPE LEAD PRODUCT ID 3708140 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2009 EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 3777-60 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2009: PRODUCT TYPE LEAD PRODUCT ID 37083-40 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2009: PRODUCT TYPE EXTENSION SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3487A, SERIAL/LOT #: (B)(6), UBD: 15-JUL-2006, UDI#: (B)(4); PRODUCT ID: 3708140, SERIAL/LOT #: (B)(6), UBD: 26-NOV-2012, UDI#: (B)(4) ; PRODUCT ID: 3777-60, SERIAL/LOT #: (B)(6), UBD: 17-DEC-2012, UDI#: (B)(4); PRODUCT ID: 37083-40, SERIAL/LOT #: (B)(6), UBD: 04-DEC-2012, UDI#: (B)(4) 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
CONTINUATION OF D10: PRODUCT ID 3487A LOT# J0220119V, IMPLANTED: (B)(6) 2002, EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3708140, SERIAL# (B)(6),IMPLANTED: (B)(6) 2009, EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 3777-60 , SERIAL# (B)(6), IMPLANTED: (B)(6) 2009, EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 37083-40 LOT# SERIAL# (B)(6) IMPLANTED:(B)(6) 2009.. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). PATIENT UNDERWENT AN IPG REPLACEMENT DUE TO END OF SERVICE AND NORMAL ERI. THE PATIENT REPORTED THAT HIS BATTERY HAD BEEN "DEAD FOR 1.5 TO 2 YEARS" SO IMPEDANCES AND CONNECTIVITY WERE UNABLE TO BE CHECKED IN PREOP. THIS WAS DISCUSSED WITH THE PHYSICIAN PRIOR TO THE SURGERY AND REMINDED INTRA OP. THE PHYSICIAN HAD DISCUSSED THIS WITH THE PATIENT AND DISCUSSED A POTENTIAL NEED FOR A LEAD REVISION IN THE FUTURE. WHEN CONNECTING THE NEW IPG THE 0-7 LEAD HAD ELECTRODES 1,2 AND 3 THAT READ GREEN AND NONE ON THE 8-15 LEAD. IMPEDANCES READ AS FOLLOWS 0)- 1) 19930 2) 1005 3)54 4) 40000 5)40000 6) 40000 7) 40000 8) 902 9) 40000 10) 40000 11) 40000. THE PHYSICIAN ATTEMPTED TO ALTERNATE THE LEADS FROM 0-7 TO 8-15 SLOT; HOWEVER, THE CONNECTIVITY AND IMPEDANCE CONCERN WAS PRESENT. THE PHYSICIAN AGAIN DISCUSSED A LEAD REVISION AND REMOVING EXTENSIONS AT A LATER DATE. FOLLOW UP WILL BE REQUIRED. IT WAS REPORTED THERE WAS LOSS OF STIMULATION.
DUE TO PREVIOUSLY REPORTED IMPEDANCE ISSUES WITH LEADS, THIS PATIENT IS SCHEDULED TO HAVE A LEAD REVISION AND POSSIBLE STIMULATOR REPLACEMENT ON (B)(6)2025. THE CURRENT LEADS ARE OUT OF RANGE AND THE PATIENT HAS NOT USED THE DEVICE SINCE REPLACEMENT OF THE GENERATOR. THE PHYSICIAN DOING THE PROCEDURE IS REMOVING ALL EXISTING LEADS, EXTENSIONS AND STIMULATOR AND REPLACING WITH NEW. THE CURRENT DEVICE IS PLACED ANTERIOR AND THE NEW DEVICE WILL BE PLACED POSTERIOR. THE PHYSICIAN IS NOT CONFIDENT THE DEVICE WILL REMAIN STERILE FOR RE-IMPLANTATION BECAUSE OF PATIENT REPOSITIONING SO NEW STIMULATOR MAY BE USED. THE PATIENT HAD/HAS LOW PLATELETS SO THIS NEEDS TO BE ADDRESSED FIRST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192957 | INCEPTIV | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 977119 | 00763000540302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Required Intervention |