FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 4174479
·
Received October 15, 2014
Report
- Report Number
- 2124215-2014-18321
- Event Type
- Injury
- Date Received
- October 15, 2014
- Date of Event
- September 11, 2014
- Report Date
- September 11, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI
- 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.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
--
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT, THIS RIGHT ATRIAL (RA) LEAD DISLODGED AND AS A RESULT THE VENTRICLE OVERSENSED THE SIGNALS AND PACED INAPPROPRIATELY. THE RA LEAD WAS REPOSITIONED SUCCESSFULLY AND REMAINS IMPLANTED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655718 | FLEXTEND | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| L| R | E162| 4087| 0276 |