FDA Adverse Event
Malfunction
Summary report: N
SELUTE PICOTIP
MDR report key: 2905478
·
Received January 9, 2013
Report
- Report Number
- 2124215-2012-13540
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- October 2, 2012
- Report Date
- October 3, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RIGHT VENTRICULAR LEAD REMAINS IMPLANTED. 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 ONE DAY POST DEVICE CHANGEOUT, LOSS OF CAPTURE FOR AN UNKNOWN DURATION WAS NOTED ON THIS CHRONIC RIGHT VENTRICULAR LEAD. IN ADDITION, IT WAS NOTED THAT THE PATIENT'S THRESHOLDS WERE INCREASED. THE OUTPUTS WERE INCREASED AND CAPTURE WAS RESUMED. THE CHRONIC LEAD REMAINS IMPLANTED AND THE PATIENT WAS TO BE MONITORED CLOSELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12017 | SELUTE PICOTIP | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4341 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | 1280| 4341 |