FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 3212548
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09341
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- May 22, 2013
- Report Date
- May 23, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED SEVERAL INAPPROPRIATE SHOCKS FOR SUPRAVENTRICULAR TACHYCARDIA (SVT), RESULTING IN EXHAUSTION OF TACHYCARDIA THERAPY. THE PATIENT WAS HOSPITALIZED FOR MONITORING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313366 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | 4512| H179| H135| N118| 4517| 1581| 1488T |