FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 2913678
·
Received January 14, 2013
Report
- Report Number
- 2124215-2012-17265
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- December 18, 2012
- Report Date
- December 19, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- PMA / PMN Number
- P010012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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 PATIENT'S HOME MONITORING EQUIPMENT DETECTED BOTH A HIGH OUT OF RANGE SHOCKING IMPEDANCE AND A LOW OUT OF RANGE SHOCK IMPEDANCE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20918 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | T177| 4543| 1774| 5076| N119| 4542| 0157| 0145 |