FDA Adverse Event
Injury
Summary report: N
THINLINE
MDR report key: 1894450
·
Received November 9, 2010
Report
- Report Number
- 2124215-2010-21550
- Event Type
- Injury
- Date Received
- November 9, 2010
- Date of Event
- April 21, 2006
- Report Date
- September 30, 2010
- Manufacturer
- GUIDANT ANGLETON/ST. PAUL
- Product Code
- NVN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT IN (B)(6) 2005, THIS PATIENT'S COMPETITIVE RIGHT VENTRICULAR LEAD(4017/(B)(4))HAD SUSTAINED INSULATION DAMAGE DURING OPEN HEART SURGERY. THEREFORE, THE LEAD WAS REMOVED FROM SERVICE, SURGICALLY ABANDONED AND REPLACED WITH ANOTHER COMPETITIVE LEAD(5076/SERIAL NUMBER UNKNOWN). IN (B)(6) 2006, THIS REPLACEMENT LEAD BECAME INFECTED AND A REVISION PROCEDURE WAS PERFORMED. THE BOSTON SCIENTIFIC PACEMAKER(1291/(B)(4)), ATRIAL LEAD (438-10-45/(B)(4)) AND THE COMPETITIVE RIGHT VENTRICULAR LEAD WERE ALL REMOVED FROM SERVICE. A NEW SYSTEM WAS IMPLANTED A FEW DAYS LATER. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THINLINE | IMPLANTABLE LEAD | NVN | GUIDANT ANGLETON/ST. PAUL | 438-10-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | 4017| 1291| (B)(4)| 293-03| 1270| 5076 |