FDA Adverse Event
Injury
Summary report: N
SWEET TIP
MDR report key: 2151722
·
Received July 6, 2011
Report
- Report Number
- 2124215-2011-06651
- Event Type
- Injury
- Date Received
- July 6, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 1, 2011
- Manufacturer
- HISTORICAL PUERTO RICO
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- 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 ATRIAL (RA) LEAD EXHIBITED SIGNS OF A LEAD FRACTURE DURING INTERROGATION AT THE CLINIC. SUBSEQUENTLY A PROCEDURE WAS PERFORMED WHERE THIS RA LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS 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 | 63 YR | Hospitalization| L| R | 4269| 1298| 4469| 1232| S606 |