FDA Adverse Event
Malfunction
Summary report: N
SWEET TIP
MDR report key: 3211185
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-10758
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 23, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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 DURING A ROUTINE CHANGE OUT PROCEDURE, THIS LEAD WAS DAMAGED. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT THE PHYSICIAN HAD INADVERTENTLY PULLED EXTREMELY HARD ON THE LEAD WHILE THE DISTAL SET SCREW WAS STILL ENGAGED. THE LEAD CAME APART BETWEEN THE TIP AND RING. THE LEAD WAS SURGICALLY ABANDONED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310454 | SWEET TIP | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4244 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | H220| 4244| 4555| 0185| 4470| 4543| 4047| N161| 4592 |