PRECISION MONTAGE MRI
Report
- Report Number
- 3006630150-2024-06638
- Event Type
- Injury
- Date Received
- October 4, 2024
- Date of Event
- November 1, 2021
- Report Date
- November 26, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7072560.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL/BATCH: (B)(6). THE DEVICES WERE RETURNED, ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. 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. IT STATES THAT THE POSSIBLE RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION INCLUDE SKIN EROSION AT THE IPG SITE CAN OCCUR OVER TIME. UNDESIRABLE STIMULATION MAY OCCUR OVER TIME DUE TO CELLULAR CHANGES IN TISSUE AROUND THE ELECTRODES, CHANGES IN ELECTRODE POSITION, LOOSE ELECTRICAL CONNECTIONS AND/OR LEAD FAILURE. LEAD MIGRATION, RESULTING IN UNDESIRABLE CHANGES IN STIMULATION AND SUBSEQUENT REDUCTION IN PAIN RELIEF. SYSTEM FAILURE, WHICH CAN OCCUR AT ANY TIME DUE TO RANDOM FAILURE(S) OF THE COMPONENTS OR THE BATTERY. THESE EVENTS, WHICH MAY INCLUDE DEVICE FAILURE, LEAD BREAKAGE, HARDWARE MALFUNCTIONS, LOOSE CONNECTIONS, ELECTRICAL SHORTS OR OPEN CIRCUITS AND LEAD INSULATION BREACHES, CAN RESULT IN INEFFECTIVE PAIN CONTROL. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS ARE ABLE TO CONFIRM THE ROOT CAUSE OF THE EVENT. THE DEVICES WERE RETURNED 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 AS KNOWN INHERENT RISK OF DEVICE.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION FROM THE SPINAL CORD STIMULATOR (SCS) SYSTEM. THE PATIENT REPORTED THAT POST IMPLANT THE THERAPY WAS ADEQUATE BUT SOMETHING HAPPENED, BUT SHE DID NOT SPECIFY WHAT, AND HENCE TURNED THE STIMULATION OFF FOR TWO YEARS, SHE ALSO REPORTED PAIN AND PROTRUSION OF THE IMPLANTABLE PULSE GENERATOR (IPG). FURTHER REVIEW DETERMINED THAT THE PATIENTS' PERIPHERAL LEAD MIGRATED, ALTHOUGH IMAGING WAS NOT AVAILABLE TO CONFIRM, CONTRIBUTING TO INADEQUATE STIMULATION. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE IPG AND THE LEAD WERE EXPLANTED, THE PATIENT IS DOING WELL POST OPERATIVELY.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION FROM THE SPINAL CORD STIMULATOR (SCS) SYSTEM. THE PATIENT REPORTED THAT POST IMPLANT THE THERAPY WAS ADEQUATE BUT SOMETHING HAPPENED, BUT SHE DID NOT SPECIFY WHAT, AND HENCE TURNED THE STIMULATION OFF FOR TWO YEARS, SHE ALSO REPORTED PAIN AND PROTRUSION OF THE IMPLANTABLE PULSE GENERATOR (IPG). FURTHER REVIEW DETERMINED THAT THE PATIENTS' PERIPHERAL LEAD MIGRATED, ALTHOUGH IMAGING WAS NOT AVAILABLE TO CONFIRM, CONTRIBUTING TO INADEQUATE STIMULATION. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE IPG AND THE LEAD WERE EXPLANTED, THE PATIENT IS DOING WELL POST OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1325709 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1200 | 373749 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention |