FLEXTEND
Report
- Report Number
- 2124215-2025-47190
- Event Type
- Injury
- Date Received
- July 15, 2025
- Date of Event
- March 9, 2021
- Report Date
- October 23, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DTB
- UDI-DI
- 00802526086632
- PMA / PMN Number
- P960006/S005
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED LEAD INSULATION DAMAGE 210-226 MILLIMETERS (MM) FROM THE LEAD TIP. THE CHARACTERISTICS OF THIS INSULATION DAMAGE WAS CONSISTENT WITH LEAD-ON-LEAD CONTACT. VISUAL INSPECTION ALSO NOTED LEAD INSULATION DAMAGE ON THE OPPOSITE SIDE AT 213-223 MILLIMETERS (MM) FROM THE TERMINAL END. THE CHARACTERISTICS OF THIS INSULATION DAMAGE WAS CONSISTENT WITH CLAVICULAR/FIRST-RIB ENTRAPMENT. TESTING WAS THEN COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. FURTHER VISUAL INSPECTION ON X-RAY DID NOT CONFIRM A LEAD FRACTURE. THE REPORTED CLINICAL OBSERVATIONS WERE LIKELY THE RESULT OF THE LEAD DAMAGE OBSERVED BY THE LABORATORY.
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD, PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING OF NOISE THAT RESULTED IN STORAGE OF A NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODE. A HEALTH CARE PROFESSIONAL (HCP) CONTACTED TECHNICAL SERVICES (TS) AND INQUIRED IF THE NOISE WAS RELATED TO ELECTROMAGNETIC INTERFERENCE (EMI). TS REVIEWED THE STORED EPISODE AND INDICATED IT WAS DIFFICULT TO DETERMINE BASED UPON THEIR REVIEW. TS RECOMMENDED PERFORMING POCKET MANIPULATIONS AND PATIENT ISOMETRICS TO TRY AND REPRODUCE NOISE. THE PATIENT WAS SEEN IN CLINIC 11 DAYS LATER. THE ROOT CAUSE OF THE NOISE WAS NOT DETERMINED. NO PACING INHIBITION WAS OBSERVED AS A RESULT OF THE OVERSENSING OF NOISE. PROGRAMMING CHANGES WERE MADE TO RA AND RV SENSITIVITY AND MONITORING WAS CONTINUED. ADDITIONAL INFORMATION WAS LATER RECEIVED THAT NOISE AND OVERSENSING CONTINUED TO BE OBSERVED ON THE RA AND RV CHANNELS. THE RA AND RV LEADS WERE NOTED TO BE FRACTURED. SURGICAL INTERVENTION WAS UNDERTAKEN. THIS PACEMAKER SYSTEM WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD, PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING OF NOISE THAT RESULTED IN STORAGE OF A NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODE. A HEALTH CARE PROFESSIONAL (HCP) CONTACTED TECHNICAL SERVICES (TS) AND INQUIRED IF THE NOISE WAS RELATED TO ELECTROMAGNETIC INTERFERENCE (EMI). TS REVIEWED THE STORED EPISODE AND INDICATED IT WAS DIFFICULT TO DETERMINE BASED UPON THEIR REVIEW. TS RECOMMENDED PERFORMING POCKET MANIPULATIONS AND PATIENT ISOMETRICS TO TRY AND REPRODUCE NOISE. THE PATIENT WAS SEEN IN CLINIC 11 DAYS LATER. THE ROOT CAUSE OF THE NOISE WAS NOT DETERMINED. NO PACING INHIBITION WAS OBSERVED AS A RESULT OF THE OVERSENSING OF NOISE. PROGRAMMING CHANGES WERE MADE TO RA AND RV SENSITIVITY AND MONITORING WAS CONTINUED. ADDITIONAL INFORMATION WAS LATER RECEIVED THAT NOISE AND OVERSENSING CONTINUED TO BE OBSERVED ON THE RA AND RV CHANNELS. THE RA AND RV LEADS WERE NOTED TO BE FRACTURED. SURGICAL INTERVENTION WAS UNDERTAKEN. THIS PACEMAKER SYSTEM WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 147002 | FLEXTEND | PERMANENT PACEMAKER ELECTRODE | DTB | BOSTON SCIENTIFIC CORPORATION | 4086 | 00802526086632 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Required Intervention| H |