FDA Adverse Event
Injury
Summary report: N
SELUTE PICOTIP
MDR report key: 2913673
·
Received January 14, 2013
Report
- Report Number
- 2124215-2013-00053
- Event Type
- Injury
- Date Received
- January 14, 2013
- Date of Event
- December 25, 2012
- Report Date
- December 25, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- 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 VENTRICULAR (RV) LEAD EXHIBITED NOISE WHICH WAS OVERSENSED AND RESULTED IN GREATER THAN TWO SECONDS OF PACING INHIBITION. IT WAS REPORTED THE PATIENT RECENTLY UNDERWENT AN AV NODE ABLATION AND BECAME PACER DEPENDENT FOLLOWING THE PROCEDURE. THE PATIENT WAS SYMPTOMATIC DUE TO THE OVERSENSED NOISE. AN INVASIVE PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20591 | SELUTE PICOTIP | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| L| R | 1290| 4054| 4035| K063 |