INFINION 16
Report
- Report Number
- 3006630150-2024-02239
- Event Type
- Malfunction
- Date Received
- April 10, 2024
- Date of Event
- March 20, 2024
- Report Date
- August 28, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729797807
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC231650E0. MODEL: SC-2316-50E. SERIAL: (B)(6). BATCH: 7231779.
SC-2316-50E ((B)(6)). THE RETURNED LEAD WAS ANALYZED AND VISUAL INSPECTION REVEALED THAT THE TOP SIX ELECTRODES WERE SEPARATED FROM THE DISTAL END AND WERE NOT RETURNED. THE CABLES WERE EXPOSED AT THE DAMAGED PORTION OF THE LEAD. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE ALLEGATION OF LEAD DAMAGE WAS CONFIRMED. THE FRACTURED CABLES REVEALED FRAYING OF THE BREAKS, LACK OF NECKING AND DISCOLORATION ASSOCIATED WITH WELDING, AND THE PROXIMITY OF THE BREAK POINTS TO THE EDGE OF THE INSULATION INDICATE THAT THE CABLES DID NOT BREAK AT OR NEAR THE WELDS. THESE OBSERVATIONS SUGGEST THAT THERE WERE NO ISSUES DURING THE WELDING PROCESS IN MANUFACTURING. IT APPEARED THAT RESISTANCE WAS FELT DURING THE LEAD PULL AND LEAD WAS SUBJECTED TO EXCESSIVE TENSILE LOAD CAUSING DAMAGE TO THE DISTAL ARRAY. SC-2316-50E ((B)(6)). THE RETURNED LEAD WAS ANALYZED, PASSED ALL TEST PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.
SC-2316-50E (SN: (B)(6)). THE RETURNED LEAD WAS ANALYZED, AND VISUAL INSPECTION REVEALED THAT THE TOP SIX ELECTRODES WERE SEPARATED FROM THE DISTAL END AND WERE NOT RETURNED. THE CABLES WERE EXPOSED AT THE DAMAGED PORTION OF THE LEAD. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE ALLEGATION OF LEAD DAMAGE WAS CONFIRMED. THE FRACTURED CABLES REVEALED FRAYING OF THE BREAKS, LACK OF NECKING AND DISCOLORATION ASSOCIATED WITH WELDING, AND THE PROXIMITY OF THE BREAK POINTS TO THE EDGE OF THE INSULATION INDICATE THAT THE CABLES DID NOT BREAK AT OR NEAR THE WELDS. THESE OBSERVATIONS SUGGEST THAT THERE WERE NO ISSUES DURING THE WELDING PROCESS IN MANUFACTURING. IT APPEARED THAT RESISTANCE WAS FELT DURING THE LEAD PULL AND LEAD WAS SUBJECTED TO EXCESSIVE TENSILE LOAD CAUSING DAMAGE TO THE DISTAL ARRAY. SC-2316-50E (SN: (B)(6)). THE RETURNED LEAD WAS ANALYZED, PASSED ALL TEST PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.
IT WAS REPORTED THAT DURING A LEAD PULL PROCEDURE, THE PHYSICIAN NOTICED THAT CONTACTS ON ONE OF THE LEADS WERE SHEARED OFF INTO THE PATIENT. IT WAS NOTED THAT THE CONTACTS WERE LEFT INSIDE THE PATIENTS BODY.
IT WAS REPORTED THAT DURING A LEAD PULL PROCEDURE, THE PHYSICIAN NOTICED THAT CONTACTS ON ONE OF THE LEADS WERE SHEARED OFF INTO THE PATIENT. IT WAS NOTED THAT THE CONTACTS WERE LEFT INSIDE THE PATIENTS BODY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD CONTACTS LEFT INSIDE THE PATIENTS BODY HAD BEEN REMOVED. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.
IT WAS REPORTED THAT DURING A LEAD PULL PROCEDURE, THE PHYSICIAN NOTICED THAT CONTACTS ON ONE OF THE LEADS WERE SHEARED OFF INTO THE PATIENT. IT WAS NOTED THAT THE CONTACTS WERE LEFT INSIDE THE PATIENTS BODY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD CONTACTS LEFT INSIDE THE PATIENTS BODY HAD BEEN REMOVED. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 411952 | INFINION 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2316-50E | 7121806 | 08714729797807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Required Intervention| O |