FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 1952180
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-23614
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 2, 2010
- Report Date
- December 2, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- PMA / PMN Number
- P010012
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 THE DEVICE SYSTEM AND LEADS WERE EXPLANTED DUE TO A PATIENT INFECTION. DURING THE PROCEDURE, A NEW RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED IN THE PACER DEPENDENT PATIENT AND CONNECTED TO THIS DEVICE OUTSIDE THE PATIENT'S BODY UNTIL A NEW SYSTEM WOULD BE IMPLANTED THE FOLLOWING WEEK. NO FURTHER COMPLICATIONS WERE OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| R | 4137| N119| 1291| 7122| 4136| 4592| 4135 |