ITREL 4
Report
- Report Number
- 3004209178-2017-20688
- Event Type
- Injury
- Date Received
- October 5, 2017
- Date of Event
- September 22, 2017
- Report Date
- April 16, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169107793
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 7495LZ25, (B)(4), IMPLANTED: (B)(6)2002 EXPLANTED: (B)(6)2018 PRODUCT TYPE EXTENSION. PRODUCT ID: 3888-28, LOT# J0230859V, IMPLANTED: (B)(6)2002 EXPLANTED: (B)(6)2018 PRODUCT TYPE LEAD. A SUPPLEMENTAL REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED AND THE RESULTS ARE AVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ANALYSIS CONFIRMED THAT NO ISSUES WERE FOUND WITH THE INS. ANALYSIS OF THE LEAD CONFIRMED THE CONDUCTOR BODY WAS BROKEN AT THE TWIST LOCK ANCHOR SITE. (B)(4). THE CONCLUSION CODE AND RESULT CODES APPLY TO THE INS. THE CONCLUSION CODE AND RESULT CODES APPLY TO THE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT SINCE REPLACEMENT OF THE PATIENT¿S INS THEY WERE UNABLE TO GET STIMULATION SENSATION. IMPEDANCES WERE RUN. C AND ANYTHING > 10K OHMS 01 2515 OHMS 02 3899 03 5078 12 2008 13 3281 23 1748 THE POCKET WAS STILL SWOLLEN AND THIS OCCURRED SINCE INS REPLACEMENT ON 2017-09-22. THE INS WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. THE REPRESENTATIVE TRIED ALL COMBOS OF PROGRAMMING ALONG WITH CHANGES TO PULSE WIDTH AND RATE AND THE PATIENT WAS STILL UNABLE TO GET THERAPY. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. THE INDICATION FOR IMPLANT WAS NON-MALIGNANT PAIN.
INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REP REPORTED THAT IMPEDANCES WERE GREATER THAN 10,000 OHMS. THE REP REPORTED THAT THEY WERE IN THE OPERATING ROOM FOR NEW IMPLANT. THE REP REPORTED THAT IMPEDANCES WERE TESTED AT 0.7V AND WERE GREATER THAN 10,000 OHMS. THE REP REPORTED THAT SHE LOST THE CONNECTION BETWEEN THE CLINICIAN PROGRAMMER AND INS AND WOULD CALL BACK. THE REP REPORTED THAT THE INS WAS ALREADY IN THE POCKET. THE REP REPORTED THAT ALL OTHER BIPOLE PAIRS WERE IN NORMAL RANGE. THE REP CALLED BACK AND REPORTED THAT THE PHYSICIAN DIDN¿T WANT TO CHECK IMPEDANCES IN THE OPERATING ROOM. THE REP ALSO REPORTED THAT THE PATIENT WASN¿T FEELING ANY STIMULATION. ALL CASE PAIR IMPEDANCES WERE OVER 10 ,000 OHMS AT 0.7V. THE REP REPORTED THAT THEY HADN¿T BEEN USING CASE PAIRS FOR PROGRAMMING BUT WERE USING THEM NOW. THE REP REPORTED THAT WHEN THEY RAN IMPEDANCES AT 1.5V, ALL WERE IN RANGE. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP). THE REP REPORTED THAT IT WAS RECOMMENDED THAT HIGH IMPEDANCES MAY RESOLVE. THE REP ALSO REPORTED THAT THE PATIENT NEVER RECEIVED STIMULATION. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT WOULD RECEIVE AN ENTIRE SYSTEM REPLACEMENT.
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP) INDICATED THAT THE LACK OF THERAPY WAS INITIALLY REPORTED BY THE PATIENT. THEY STATED THAT NO ACTIONS HAVE BEEN TAKEN AS A RESULT OF THE EVENT YET. THE REP NOTED THAT THEY PLAN TO WAIT AND SEE IF THE IMPEDANCES RETURN TO LOWER VALUES AS THE PATIENT¿S POCKET SWELLING DIMINISHES. THE REP ALSO INDICATED THAT THEY RAN IMPEDANCES AT 3V, WHICH WERE READINGS MOSTLY AROUND 15,000-17,000 OHMS. THE PATIENT¿S NEXT VISIT IS ON (B)(6) 2017, AND THE REP WILL SEE IF THEY CAN GET ADEQUATE COVERAGE. A LEAD REVISION WILL BE DISCUSSED IF ADEQUATE COVERAGE CANNOT BE OBTAINED. NO FURTHER COMPLICATIONS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PATIENT DID NOT FEEL STIMULATION AFTER THE INITIAL REPLACEMENT OF THE INS, THEREFOR THE LEADS AND INS WERE REPLACED. IMPEDANCE RESTING WAS PREVIOUSLY PERFORMED. SEVERAL IMPEDANCES REMAINED HIGHER THAN EXPECTED, THEREFORE THE ENTIRE SYSTEM WAS REPLACED. THE ISSUE IS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE ON 2018-JAN-30 CLARIFYING THAT THE REPLACEMENT OCCURRED ON (B)(6)2018. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 697746 | ITREL 4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37703 | 00643169107793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |