PRECISION MONTAGE MRI
Report
- Report Number
- 3006630150-2022-03005
- Event Type
- Injury
- Date Received
- June 21, 2022
- Date of Event
- June 2, 2022
- Report Date
- May 3, 2023
- 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
- SC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI; UPN: M365SC8416500; MODEL: SC-8416-50; SERIAL: (B)(4); BATCH: 7070427.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI; UPN: M365SC8416500; MODEL: SC-8416-50; SERIAL: (B)(6); BATCH: 7070427.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI, UPN: M365SC8416500, MODEL: SC-8416-50, SERIAL: (B)(6), BATCH: 7070427.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI, UPN: M365SC8416500, MODEL: SC-8416-50, SERIAL: (B)(6), BATCH: 7070427. THE IPG WAS RETURNED, ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE PADDLE LEAD WAS RETURNED AND VISUAL AND X-RAY INSPECTION REVEALED THAT ELECTRODE # 8 IS DISLODGED AND THE CABLE CONNECTION TO IT IS FRACTURED. THE FRACTURED CABLE AND DAMAGED ELECTRODE DO NOT SHOW SIGNS OF CORROSION. THE PADDLE IS NOT DEFORMED, ADDITIONALLY, THE LEAD BODIES WERE CLEANLY CUT. THE CLIK ANCHORS ARE STILL ATTACHED TO THE LEAD, DAMAGE TO THE ELECTRODE AND LEAD BODIES IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. A LABELING REVIEW WAS PERFORMED ON THE IMPLANTABLE PULSE GENERATOR, IPG, AND LEADS INSTRUCTIONS FOR USE, IFU. THERE WAS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELED INDICATIONS. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS ARE ABLE TO CONFIRM THE ROOT CAUSE OF THE EVENT. THE DEVICES WERE RETURNED AND ANALYZED, AS SUCH PHYSICAL ANALYSIS WAS CONDUCTED, RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS ABLE TO DETERMINE A PROBABLE ROOT CAUSE FOR THE COMPLAINT AND THE CONCLUSION IS KNOWN INHERENT RISK OF THE DEVICE.
IT WAS REPORTED THAT THE PATIENT, THAT IS ENROLLED IN THE A7007 CLINICAL STUDY EXPERIENCED OVERSTIMULATION, CHEST TIGHTNESS, AND BILATERAL SHOULDER TIGHTNESS DURING A SCHEDULED REPROGRAMMING FOLLOW UP APPOINTMENT. THE STIMULATION WAS TURNED OFF AND THE PATIENT WAS REFERRED TO ER, EMERGENCY ROOM, WHERE AN EKG, ELECTROCARDIOGRAM, AND LABS WERE TAKEN, AND THE RESULTS WERE NORMAL. THE PATIENT WAS GIVEN MEDICATION AND RELEASED THE FOLLOWING MORNING. IT WAS INDICATED THAT THE OVERSTIMULATION WAS CAUSED BY THE IPG, IMPLANTABLE PULSE GENERATOR, HOWEVER, IMAGING CONFIRMED THAT THE PADDLE LEAD WAS NOT STRAIGHT, AND THAT IT LOOKED WAVY, AND MAY HAVE BEEN THE CAUSE OF IMPEDANCE FLUCTUATIONS. THE EVENT WAS ASSESSED AS CAUSALLY RELATED TO THE STIMULATION AND NOT RELATED TO THE DEVICE ITSELF OR THE PROCEDURE. THE EVENT IS RESOLVING.
IT WAS REPORTED THAT THE PATIENT, THAT IS ENROLLED IN THE A7007 CLINICAL STUDY, EXPERIENCED OVERSTIMULATION, CHEST TIGHTNESS, AND BILATERAL SHOULDER TIGHTNESS DURING A SCHEDULED REPROGRAMMING FOLLOW UP APPOINTMENT. THE STIMULATION WAS TURNED OFF AND THE PATIENT WAS REFERRED TO ER, EMERGENCY ROOM, WHERE AN EKG, ELECTROCARDIOGRAM, AND LABS WERE TAKEN, THE RESULTS WERE NORMAL. THE PATIENT WAS GIVEN MEDICATION AND RELEASED THE FOLLOWING MORNING. IT WAS INDICATED THAT THE OVERSTIMULATION WAS CAUSED BY THE IPG, IMPLANTABLE PULSE GENERATOR, HOWEVER, IMAGING CONFIRMED THAT THE PADDLE LEAD WAS NOT STRAIGHT, AND THAT IT LOOKED WAVY, AND MAY HAVE BEEN THE CAUSE OF THE IMPEDANCE FLUCTUATIONS. THE EVENT WAS ASSESSED AS CAUSALLY RELATED TO THE STIMULATION AND NOT RELATED TO THE DEVICE ITSELF OR THE PROCEDURE. THE EVENT IS RESOLVING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED NON CARDIAC BILATERAL TIGHTNESS AND THAT THE STIMULATION WAS TURNED OFF PRIOR TO BEING TRANSPORTED TO THE ER. THE PATIENT FELT BETTER AFTER MEDICATION AND FLUIDS WERE ADMINISTERED. THE PATIENT UNDERWENT AN IPG AND LEAD EXPLANT PROCEDURE SEVERAL MONTHS LATER AND WITHDREW FROM THE CLINICAL STUDY.
IT WAS REPORTED THAT THE PATIENT, THAT IS ENROLLED IN THE A7007 CLINICAL STUDY EXPERIENCED OVERSTIMULATION, CHEST TIGHTNESS, AND BILATERAL SHOULDER TIGHTNESS DURING A SCHEDULED REPROGRAMMING FOLLOW UP APPOINTMENT. THE STIMULATION WAS TURNED OFF AND THE PATIENT WAS REFERRED TO ER, EMERGENCY ROOM, WHERE AN EKG, ELECTROCARDIOGRAM, AND LABS WERE TAKEN, AND THE RESULTS WERE NORMAL. THE PATIENT WAS GIVEN MEDICATION AND RELEASED THE FOLLOWING MORNING. IT WAS INDICATED THAT THE OVERSTIMULATION WAS CAUSED BY THE IPG, IMPLANTABLE PULSE GENERATOR, HOWEVER, IMAGING CONFIRMED THAT THE PADDLE LEAD WAS NOT STRAIGHT, AND THAT IT LOOKED WAVY, AND MAY HAVE BEEN THE CAUSE OF IMPEDANCE FLUCTUATIONS. THE EVENT WAS ASSESSED AS CAUSALLY RELATED TO THE STIMULATION AND NOT RELATED TO THE DEVICE ITSELF OR THE PROCEDURE. THE EVENT IS RESOLVING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CHEST TIGHTNESS RESOLVED IN THE ER AND THE BILATERAL TIGHTNESS WAS RESOLVING. THE PATIENT HAS NOT TURNED THE STIMULATION BACK ON.
IT WAS REPORTED THAT THE PATIENT, THAT IS ENROLLED IN THE A7007 CLINICAL STUDY, EXPERIENCED OVERSTIMULATION, CHEST TIGHTNESS, AND BILATERAL SHOULDER TIGHTNESS DURING A SCHEDULED REPROGRAMMING FOLLOW UP APPOINTMENT. THE STIMULATION WAS TURNED OFF AND THE PATIENT WAS REFERRED TO ER, EMERGENCY ROOM, WHERE AN EKG, ELECTROCARDIOGRAM, AND LABS WERE TAKEN, THE RESULTS WERE NORMAL. THE PATIENT WAS GIVEN MEDICATION AND RELEASED THE FOLLOWING MORNING. IT WAS INDICATED THAT THE OVERSTIMULATION WAS CAUSED BY THE IPG, IMPLANTABLE PULSE GENERATOR, HOWEVER, IMAGING CONFIRMED THAT THE PADDLE LEAD WAS NOT STRAIGHT, AND THAT IT LOOKED WAVY, AND MAY HAVE BEEN THE CAUSE OF THE IMPEDANCE FLUCTUATIONS. THE EVENT WAS ASSESSED AS CAUSALLY RELATED TO THE STIMULATION AND NOT RELATED TO THE DEVICE ITSELF OR THE PROCEDURE. THE EVENT IS RESOLVING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED NON CARDIAC BILATERAL TIGHTNESS AND THAT THE STIMULATION WAS TURNED OFF PRIOR TO BEING TRANSPORTED TO THE ER. THE PATIENT FELT BETTER AFTER MEDICATION AND FLUIDS WERE ADMINISTERED. THE PATIENT UNDERWENT AN IPG AND LEAD EXPLANT PROCEDURE SEVERAL MONTHS LATER AND WITHDREW FROM THE CLINICAL STUDY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 201429 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 369357 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention |