AVISTA? MRI
Report
- Report Number
- 3006630150-2026-00487
- Event Type
- Injury
- Date Received
- January 23, 2026
- Date of Event
- November 5, 2025
- Report Date
- April 6, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729904823
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE SC-1232; (B)(6) WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET SPECIFICATION PRIOR TO SHIPPING. NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF: UNABLE TO EXCLUDE DEVICE PROBLEM. THE DEVICE SC-2408-74; (B)(6) WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES THAT LEAD MIGRATION, RESULTING IN UNDESIRABLE CHANGES IN STIMULATION AND SUBSEQUENT REDUCTION IN PAIN RELIEF IS A KNOWN RISK WITH THE USE OF SPINAL CORD STIMULATION (SCS). BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF: KNOWN INHERENT RISK OF DEVICE. THE DEVICE SC-2408-74; (B)(6) WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES THAT LEAD MIGRATION, RESULTING IN UNDESIRABLE CHANGES IN STIMULATION AND SUBSEQUENT REDUCTION IN PAIN RELIEF IS A KNOWN RISK WITH THE USE OF SPINAL CORD STIMULATION (SCS). BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF: KNOWN INHERENT RISK OF DEVICE. B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12320. MODEL: SC-1232. SERIAL: (B)(6). BATCH: 790708. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408740. MODEL: SC-2408-74. SERIAL: (B)(6). BATCH: 7080404. UDI: (B)(4).
B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12320. MODEL: SC-1232. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408740. MODEL: SC-2408-74. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).
IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED AND REPLACED DUE TO MIGRATION AND CHARGING DIFFICULTIES, RESPECTIVELY. ELECTROCAUTERY WAS USED. THE IPG AND LEADS WERE RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING WELL.
IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED AND REPLACED DUE TO MIGRATION AND CHARGING DIFFICULTIES, RESPECTIVELY. ELECTROCAUTERY WAS USED. THE IPG AND LEADS WERE RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228655 | AVISTA? MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2408-74 | 7080329 | 08714729904823 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Required Intervention |