FDA Adverse Event
Malfunction
Summary report: N
SELUTE PICOTIP
MDR report key: 2172960
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10820
- Event Type
- Malfunction
- Date Received
- July 23, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 9, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS RV LEAD WAS SURGICALLY ABANDONED. NO FURTHER INFORMATION IS EXPECTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID EXHIBIT IMPENDING FRACTURE ASSOCIATED WITH ELEVATED IMPEDANCES AND ELEVATED THRESHOLDS. IMPEDANCES HADNEVER BEEN OUTSIDE NORMAL LIMITS, HOWEVER THE PHYSICIAN DETERMINED TO REPLACE THIS LEAD DURING GENERATOR REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS SURGICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELUTE PICOTIP | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention | 4470| 1270| S606| 4034| 4053 |