MOMENTUM? EL ICD DR
Report
- Report Number
- 2124215-2026-24619
- Event Type
- Malfunction
- Date Received
- May 6, 2026
- Date of Event
- April 17, 2026
- Report Date
- May 11, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526587726
- PMA / PMN Number
- P960040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE REMAINS IN SERVICE; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. 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 REMAINS IN SERVICE; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS HIGHER THAN 200 OMHS. TECHNICAL SERVICES (TS) WAS CONTACTED AND RECOMMENDED FOLLOW UP. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED DETAILED THAT WHEN THE PATIENT WAS CHECKED NEXT, SHOCK IMPEDANCE MEASUREMENTS WERE 84 OHMS.
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS HIGHER THAN 200 OMHS. TECHNICAL SERVICES (TS) WAS CONTACTED AND RECOMMENDED FOLLOW UP. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456796 | MOMENTUM? EL ICD DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | D121 | 245709 | 00802526587726 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |