FDA Adverse Event
Injury
Summary report: N
COGNIS
MDR report key: 1871677
·
Received October 15, 2010
Report
- Report Number
- 2124215-2010-18592
- Event Type
- Injury
- Date Received
- October 15, 2010
- Date of Event
- August 26, 2010
- Report Date
- August 26, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) DEVELOPED A SMALL PNEUMOTHORAX ON THE SAME DAY OF THE IMPLANT PROCEDURE. THE PNEUMOTHORAX WAS REPORTED TO HAVE RESOLVED SPONTANEOUSLY. THERE WERE NO 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 | N119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Life Threatening | 4543| 0185| 4076| N119| MISMATCH |