FDA Adverse Event
Injury
Summary report: N
SWEET TIP
MDR report key: 2052874
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04638
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- April 27, 1999
- Report Date
- February 25, 2011
- Manufacturer
- HISTORICAL PUERTO RICO
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD WAS CAPPED AND SURGICALLY ABANDONED. A NEW LEAD WAS SUCCESSFULLY 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 THIS RIGHT VENTRICULAR (RV) LEAD HAD FRACTURED. AN INVASIVE PROCEDURE WAS PERFORMED AND THIS LEAD WAS CAPPED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWEET TIP | IMPLANTABLE LEAD | NVN | HISTORICAL PUERTO RICO | 4269 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | 0125| 4269| 1762| 4245| 1793 |