FDA Adverse Event
Injury
Summary report: N
FLEXTEND II
MDR report key: 4131669
·
Received October 1, 2014
Report
- Report Number
- 2124215-2014-13885
- Event Type
- Injury
- Date Received
- October 1, 2014
- Date of Event
- July 11, 2014
- Report Date
- July 11, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT APPROXIMATELY TWO DAYS POST-IMPLANT, THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED TO THE HOSPITAL WITH BRADYCARDIA, AT A RATE OF 44 BPM. AN X-RAY REVEALED THE RV LEAD HAD DISLODGED. THE PATIENT WAS THEN HOSPITALIZED AND THE LEAD SUCCESSFULLY SURGICALLY REPOSITIONED. THE RV LEAD REMAINS IMPLANTED AND IN SERVICE WITH NO FURTHER ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612580 | FLEXTEND II | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| L| R | 4097| K184| 4096 |