PRECISION MONTAGE MRI
Report
- Report Number
- 3006630150-2021-02843
- Event Type
- Injury
- Date Received
- June 10, 2021
- Date of Event
- April 26, 2021
- Report Date
- January 31, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7072232.
SC-1200, SERIAL (B)(6): ENGINEERS INSPECTED AND ANALYZED THIS DEVICE UPON RECEIPT. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM RESET COUNT WAS 3, THAT SUGGESTED NO STIMULATION INTERRUPTION DUE TO IPG MALFUNCTION PRIOR TO THE PRODUCT RETURN. MONITORED STIMULATION ON AN OSCILLOSCOPE FOUND THE OUTPUTS WERE CONSISTENT AND CORRECT ON ALL ELECTRODES. CURRENT LEAKAGE TESTS AND RESIDUAL GAS ANALYSIS VERIFIED NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE. THE COMPLAINT OF THE IPG SWITCHING OFF WAS NOT CONFIRMED. IT PASSED THE FUNCTIONAL TEST, AND AN ELECTRICAL TEST REVEALED NORMAL DEVICE CHARACTERISTICS. SC-2317-70, SERIAL (B)(6): THE COMPLAINT OF HIGH IMPEDANCES ON ONE OF THE LEADS WAS CONFIRMED. VISUAL AND X-RAY INSPECTIONS OF THE RETURNED LEAD CONFIRMED SEVEN CABLES WERE FRACTURED AT THE CLIK SITE, ABOUT 15.5 CENTIMETERS FROM THE DISTAL END THAT RESULTED IN THE SOURCE OF HIGH IMPEDANCES.
SC-1200, (B)(6). ENGINEERS INSPECTED AND ANALYZED THIS DEVICE UPON RECEIPT. THE IPG SYSTEM RESET COUNT WAS 3, THAT SUGGESTED NO STIMULATION INTERRUPTION DUE TO IPG MALFUNCTION PRIOR TO THE PRODUCT RETURN. MONITORED STIMULATION ON AN OSCILLOSCOPE FOUND THE OUTPUTS WERE CONSISTENT AND CORRECT ON ALL ELECTRODES. CURRENT LEAKAGE TESTS AND RESIDUAL GAS ANALYSIS VERIFIED NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE. THE HIGHEST TEMPERATURE DURING CHARGING CYCLES IN THE PATIENTS BODY REGISTERED WITHIN THE ACCEPTABLE RANGE IT PASSED THE FUNCTIONAL TEST, AND AN ELECTRICAL TEST REVEALED NORMAL DEVICE CHARACTERISTICS. SC-2317-70, (B)(6). THE COMPLAINT OF HIGH IMPEDANCES ON ONE OF THE LEADS WAS CONFIRMED. VISUAL AND X-RAY INSPECTIONS OF THE RETURNED LEAD CONFIRMED SEVEN CABLES WERE FRACTURED AT THE CLIK SITE, ABOUT 15.5 CENTIMETERS FROM THE DISTAL END THAT RESULTED IN THE SOURCE OF HIGH IMPEDANCES. WHEN EXCESSIVE MECHANICAL-TENSILE FORCE WAS EXERTED ONTO THE LEAD, THE LEAD BECAME KINKED AFTER EXITING THE CLIK ANCHOR RESULTING IN THE CABLE FRACTURES.
SC-1200, SERIAL (B)(6): ENGINEERS INSPECTED AND ANALYZED THIS DEVICE UPON RECEIPT. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM RESET COUNT WAS 3, THAT SUGGESTED NO STIMULATION INTERRUPTION DUE TO IPG MALFUNCTION PRIOR TO THE PRODUCT RETURN. MONITORED STIMULATION ON AN OSCILLOSCOPE FOUND THE OUTPUTS WERE CONSISTENT AND CORRECT ON ALL ELECTRODES. CURRENT LEAKAGE TESTS AND RESIDUAL GAS ANALYSIS VERIFIED NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE. THE COMPLAINT OF THE IPG SWITCHING OFF WAS NOT CONFIRMED. IT PASSED THE FUNCTIONAL TEST, AND AN ELECTRICAL TEST REVEALED NORMAL DEVICE CHARACTERISTICS. SC-2317-70, SERIAL (B)(6): THE COMPLAINT OF HIGH IMPEDANCES ON ONE OF THE LEADS WAS CONFIRMED. VISUAL AND X-RAY INSPECTIONS OF THE RETURNED LEAD CONFIRMED SEVEN CABLES WERE FRACTURED AT THE CLIK SITE, ABOUT 15.5 CENTIMETERS FROM THE DISTAL END THAT RESULTED IN THE SOURCE OF HIGH IMPEDANCES.
IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS AFTER THE PERMANENT IMPLANT PROCEDURE THE IMPLANTABLE PULSE GENERATOR (IPG) STARTED TO SWITCH OFF ON ITS OWN. IN ADDITION, THE PATIENT WAS EXPERIENCING A PARTIAL LOSS OF THERAPY. AN IMPEDANCE CHECK REVEALED MULTIPLE CONTACTS OF THE LEAD DISPLAYED HIGH IMPEDANCES. REPROGRAMMING WAS ATTEMPTED, HOWEVER THE IPG CONTINUED SWITCHING OFF. THE PATIENT REPORTED THERE WERE NO SITUATIONS THAT WOULD HAVE EXPOSED THE PATIENT TO LARGE MAGNETIC FIELDS ETC. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PHYSICIAN REPLACED THE ENTIRE SYSTEM. THE EXPLANTED IPG AND LEAD WILL BE RETURNED. THE PATIENT IS DOING WELL POST OPERATIVELY.
IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS AFTER THE PERMANENT IMPLANT PROCEDURE THE IMPLANTABLE PULSE GENERATOR (IPG) STARTED TO SWITCH OFF ON ITS OWN. IN ADDITION, THE PATIENT WAS EXPERIENCING A PARTIAL LOSS OF THERAPY. AN IMPEDANCE CHECK REVEALED MULTIPLE CONTACTS OF THE LEAD DISPLAYED HIGH IMPEDANCES. REPROGRAMMING WAS ATTEMPTED, HOWEVER THE IPG CONTINUED SWITCHING OFF. THE PATIENT REPORTED THERE WERE NO SITUATIONS THAT WOULD HAVE EXPOSED THE PATIENT TO LARGE MAGNETIC FIELDS ETC. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PHYSICIAN REPLACED THE ENTIRE SYSTEM. THE EXPLANTED IPG AND LEAD WILL BE RETURNED. THE PATIENT IS DOING WELL POST OPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ALSO EXPERIENCING A WARMING SENSATION AT THE IPG SITE.
IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS AFTER THE PERMANENT IMPLANT PROCEDURE THE IMPLANTABLE PULSE GENERATOR (IPG) STARTED TO SWITCH OFF ON ITS OWN. IN ADDITION, THE PATIENT WAS EXPERIENCING A PARTIAL LOSS OF THERAPY. AN IMPEDANCE CHECK REVEALED MULTIPLE CONTACTS OF THE LEAD DISPLAYED HIGH IMPEDANCES. REPROGRAMMING WAS ATTEMPTED, HOWEVER THE IPG CONTINUED SWITCHING OFF. THE PATIENT REPORTED THERE WERE NO SITUATIONS THAT WOULD HAVE EXPOSED THE PATIENT TO LARGE MAGNETIC FIELDS ETC. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PHYSICIAN REPLACED THE ENTIRE SYSTEM. THE EXPLANTED IPG AND LEAD WILL BE RETURNED. THE PATIENT IS DOING WELL POST OPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ALSO EXPERIENCING A WARMING SENSATION AT THE IPG SITE.
IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS AFTER THE PERMANENT IMPLANT PROCEDURE THE IMPLANTABLE PULSE GENERATOR (IPG) STARTED TO SWITCH OFF ON ITS OWN. IN ADDITION, THE PATIENT WAS EXPERIENCING A PARTIAL LOSS OF THERAPY. AN IMPEDANCE CHECK REVEALED MULTIPLE CONTACTS OF THE LEAD DISPLAYED HIGH IMPEDANCES. REPROGRAMMING WAS ATTEMPTED, HOWEVER THE IPG CONTINUED SWITCHING OFF. THE PATIENT REPORTED THERE WERE NO SITUATIONS THAT WOULD HAVE EXPOSED THE PATIENT TO LARGE MAGNETIC FIELDS ETC. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PHYSICIAN REPLACED THE ENTIRE SYSTEM. THE EXPLANTED IPG AND LEAD WILL BE RETURNED. THE PATIENT IS DOING WELL POST OPERATIVELY.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(4). BATCH: 7072232.
IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS AFTER THE PERMANENT IMPLANT PROCEDURE THE IMPLANTABLE PULSE GENERATOR (IPG) STARTED TO SWITCH OFF ON ITS OWN. IN ADDITION, THE PATIENT WAS EXPERIENCING A PARTIAL LOSS OF THERAPY. AN IMPEDANCE CHECK REVEALED MULTIPLE CONTACTS OF THE LEAD DISPLAYED HIGH IMPEDANCES. REPROGRAMMING WAS ATTEMPTED, HOWEVER THE IPG CONTINUED SWITCHING OFF. THE PATIENT REPORTED THERE WERE NO SITUATIONS THAT WOULD HAVE EXPOSED THE PATIENT TO LARGE MAGNETIC FIELDS ETC. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PHYSICIAN REPLACED THE ENTIRE SYSTEM. THE EXPLANTED IPG AND LEAD WILL BE RETURNED. THE PATIENT IS DOING WELL POST OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 873667 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 370617 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |