FDA Adverse Event
Malfunction
Summary report: N
SELUTE PICOTIP
MDR report key: 3043183
·
Received April 9, 2013
Report
- Report Number
- 2124215-2013-01876
- Event Type
- Malfunction
- Date Received
- April 9, 2013
- Date of Event
- January 23, 2013
- Report Date
- January 23, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION. INTERMITTENT UNDERSENSING OF THE ATRIAL SIGNAL WAS NOTED. THE LEAD IMPEDANCES WAS LOW AND INSULATION DAMAGE WAS SUSPECTED. THE DEVICE WAS REPROGRAMMED. NO FURTHER ACTION WAS PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144998 | SELUTE PICOTIP | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |