FDA Adverse Event
Injury
Summary report: N
SWEET PICOTIP
MDR report key: 3243299
·
Received July 23, 2013
Report
- Report Number
- 2124215-2013-11769
- Event Type
- Injury
- Date Received
- July 23, 2013
- Date of Event
- June 27, 2013
- Report Date
- June 27, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 WAS SURGICALLY ABANDONED DUE TO PACING NOT DELIVERED WHEN REQUIRED WITH ASYSTOLE. THE LEAD PROGRAMMING WAS CHANGED WHICH ALLEVIATED THE ISSUE, BUT THE PHYSICIAN WANTED A NEW LEAD ANYWAY. THE LEAD WAS SUCCESSFULLY REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342631 | SWEET PICOTIP | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| L| R | 4055| K173| 4054| 1294| 4471| 1274 |