FDA Adverse Event
Injury
Summary report: N
INSIGNIA
MDR report key: 1944759
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-20061
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- October 10, 2010
- Report Date
- October 10, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED AN EPISODE OF SYNCOPE. THE DEVICE WAS CHECKED IN THE HOSPITAL AND FUSION BEATS WERE NOTED. IT WAS UNKNOWN IF THE FUSION BEATS CAUSED THE PATIENT SYNCOPE. ALSO REPORTED WAS RIGHT ATRIAL (RA) LEAD SENSING WAS INCREASED TO ENSURE SENSING THE P-WAVE MEASUREMENTS. THE PACEMAKER OTHERWISE WAS FUNCTIONING WITHIN NORMAL LIMITS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Life Threatening | 1290| 4137| 4470 |