FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1962268
·
Received January 18, 2011
Report
- Report Number
- 2124215-2011-00832
- Event Type
- Injury
- Date Received
- January 18, 2011
- Date of Event
- December 14, 2010
- Report Date
- December 14, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST IMPLANT THE FIELD REPRESENTATIVE SUSPECTED THIS PATIENT DEVELOPED CARDIAC TAMPONADE. RIGHT ATRIAL (RA) UNDERSENSING OF SMALL ATRIAL FIBRILLATION WAVES AND OVERSENSING OF NOISE WAS REPORTED. WHEN THE FIELD REPRESENTATIVE INCREASES THE DEVICE SENSITIVITY, OVERSENSING IS THEN OBSERVED. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED PROGRAMMING OPTIONS TO REDUCE THE AMOUNT OF UNDERSENSING AND NOISE. ADDITIONAL INFORMATION WAS REQUESTED ABOUT THE CARDIAC TAMPONADE HOWEVER NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Life Threatening | 4087| S603| 4086 |