FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND
MDR report key: 2913336
·
Received January 14, 2013
Report
- Report Number
- 2124215-2013-00592
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- December 17, 2012
- Report Date
- December 17, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) IMPEDANCES OF GREATER THAN 2300 OHMS. THE IMPEDANCES CAUSED A LEAD SAFETY SWITCH (LSS) AND IT LOOKS AS IF THEY HAVE BEEN RISING FOR GREATER THAN A YEAR. THERE WAS ALSO LOSS OF CAPTURE (LOC) AS WELL AS LEAD FRACTURE, OR SETSCREW ISSUES. THE PATIENT HAD NOT BEEN SEEN FOR A VERY LONG TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20204 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | 4088| 4087| 1297 |