FDA Adverse Event
Injury
Summary report: N
THINLINE
MDR report key: 4131660
·
Received October 1, 2014
Report
- Report Number
- 2124215-2014-14132
- Event Type
- Injury
- Date Received
- October 1, 2014
- Date of Event
- July 10, 2014
- Report Date
- July 10, 2014
- Manufacturer
- GUIDANT ANGLETON/ST. PAUL
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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 THIS RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING RESULTING IN PACING INHIBITION. IT WAS DETERMINED THE LEAD HAD FRACTURED. AN INVASIVE PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612577 | THINLINE | IMPLANTABLE LEAD | NVY | GUIDANT ANGLETON/ST. PAUL | 438-10-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| L| R | 430-10| 1274| K174| 5076| 438-10-52| 4136| 1290 |