FDA Adverse Event
Injury
Summary report: N
SELUTE PICOTIP
MDR report key: 3951190
·
Received July 22, 2014
Report
- Report Number
- 2124215-2014-14274
- Event Type
- Injury
- Date Received
- July 22, 2014
- Date of Event
- May 3, 2014
- Report Date
- May 21, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING, PACING INHIBITION WITH MORE THAN 2 SECONDS ASYSTOLE, AND HIGH PACING THRESHOLD MEASUREMENTS. THE LEAD WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THE DEVICE WAS ELECTIVELY REPLACED DUE TO NORMAL BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 427531 | SELUTE PICOTIP | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization| L| R | 4285| 4269| 4035| 1294| 1296| S606| 1230| 1388TC |