FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 10089651
·
Received May 26, 2020
Report
- Report Number
- 2124215-2020-07355
- Event Type
- Malfunction
- Date Received
- May 26, 2020
- Date of Event
- April 4, 2020
- Report Date
- May 26, 2020
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- PMA / PMN Number
- P960040/S155
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 0
THIS SUPPLEMENTAL REPORT IS BEING FILED TO INCLUDE A CONCLUSION CODE UPDATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCK IMPEDANCES RANGING FROM 121-127 OHMS. IT WAS ALSO OBSERVED THAT THIS PATIENT HEARD BEEPING TONES , HOWEVER THIS IS EXPECTED BEHAVIOR DUE TO THE ALERT OF OUT OF RANGE IMPEDANCES BEING PROGRAMMED ON. TECHNICAL SERVICES DISCUSSED PROGRAMMING OPTIONS OR TO PERFORM A COMMANDED SHOCK. THIS ICD AND RV LEAD REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553263 | TELIGEN | IMPLANTABLE DEVICE | LWP | BOSTON SCIENTIFIC CORPORATION | E102 | 265192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |