FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1863998
·
Received October 11, 2010
Report
- Report Number
- 2124215-2010-15605
- Event Type
- Injury
- Date Received
- October 11, 2010
- Date of Event
- August 4, 2010
- Report Date
- August 4, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD REMAINS IMPLANTED. 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 CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THE DEVICE WAS PROGRAMMED TO DDD AND THE ATRIAL PORT WAS OPEN. THE DEVICE WAS OUT OF THE POCKET AND TWO BEATS OF INHIBITION OF PACING WERE NOTED. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT SUGGESTED THAT THE OPEN ATRIAL PORT IN DDD, LOOSE SETSCREWS OR MOVEMENT OF THE DEVICE CREATING CHATTER ON THE VENTRICULAR LEAD COULD HAVE CAUSED THE PACING INHIBITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Life Threatening | 4034| 1286| 4087| 4086 |