FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 2052585
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-03596
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- February 25, 2011
- Report Date
- February 25, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT PROVIDED THE PATIENT WITH INFORMATION CONCERNING AVOIDANCE OF ELECTROMAGNETIC INTERFERENCE. 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 PATIENT IMPLANTED WITH THIS DEVICE STOOD NEAR A FREEZER. THE PATIENT THEN BECAME DIZZY AND FAINTED, SUFFERING A BROKEN NOSE. IT WAS ALSO REPORTED THE RELATED LEFT VENTRICULAR (LV) LEAD WAS DISLODGED AFTER THE FALL. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Life Threatening| O | N107| 0185| 4087| 4592 |