FDA Adverse Event
Malfunction
Summary report: N
THINLINE
MDR report key: 1871878
·
Received October 16, 2010
Report
- Report Number
- 2124215-2010-17548
- Event Type
- Malfunction
- Date Received
- October 16, 2010
- Date of Event
- August 27, 2010
- Report Date
- August 27, 2010
- Manufacturer
- GUIDANT ANGLETON/ST. PAUL
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A DEVICE REPLACEMENT PROCEDURE, THIS RIGHT VENTRICULAR LEAD WAS REMOVED AND THE CONNECTION WAS VERIFIED. WHEN THE LEAD WAS RECONNECTED TO THE REPLACEMENT DEVICE, IT WAS NOTED THIS LEAD'S OUTER INSULATION APPEARED DAMAGED NEAR THE TERMINAL PIN AND THE CONDUCTOR COILS WERE STRETCHED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THINLINE | IMPLANTABLE LEAD | NVN | GUIDANT ANGLETON/ST. PAUL | 430-10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | 432-04| 294-03| 430-10 |