FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 2042396
·
Received April 6, 2011
Report
- Report Number
- 2124215-2011-02117
- Event Type
- Injury
- Date Received
- April 6, 2011
- Date of Event
- January 19, 2011
- Report Date
- January 19, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A PACING THRESHOLD TEST, THE LOCAL FIELD REPRESENTATIVE (FR) REPORTED TO HAVE LOST RADIO FREQUENCY (RFD) ABILITIES. THE THRESHOLD TEST DID NOT END WHEN DESIRED. THE PATIENT IS PACEMAKER DEPENDANT AND NEARLY BECAME SYNCOPAL. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Life Threatening | MISMATCH| H179| 0184| 4517| N118 |