FDA Adverse Event
Malfunction
Summary report: N
INGEVITY
MDR report key: 4140014
·
Received October 3, 2014
Report
- Report Number
- 2124215-2014-16428
- Event Type
- Malfunction
- Date Received
- October 3, 2014
- Date of Event
- August 5, 2014
- Report Date
- September 9, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION CONFIRMED THAT THE CATHODE CONDUCTOR COIL WAS FRACTURED APPROXIMATELY 8MM FROM THE TIP OF THE LEAD. MICROSCOPIC ANALYSIS CONFIRMED THAT THE FAILURE MECHANISM WAS DUE TO TORSIONAL OVERSTRESS.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS NOT SUCCESSFULLY IMPLANTED AFTER THE HELIX MECHANISM BECAME NON-FUNCTIONAL AFTER ATTEMPTS TO REPOSITION IT. THE LEAD WAS EXPLANTED AND REPLACED WITHOUT ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 620247 | INGEVITY | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 7741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7741 |