FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 2162604
·
Received July 14, 2011
Report
- Report Number
- 2124215-2011-07169
- Event Type
- Injury
- Date Received
- July 14, 2011
- Date of Event
- April 8, 2011
- Report Date
- April 19, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
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 RECEIVED AN INAPPROPRIATE SHOCK FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) WHICH DEGRADED THE PATIENT'S RHYTHM TO VENTRICULAR FIBRILLATION (VF), WITH RESULTING SYNCOPE. THE DEVICE DID SUCCESSFULLY CONVERT THE PATIENT OUT OF VF. REPROGRAMMING OF THE DEVICE ZONES AND THERAPY WAS COMPLETED TO ATTEMPT TO PREVENT FURTHER EVENTS. NO FURTHER ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
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 | 51 YR | Life Threatening | 0158| N119| 4136 |