FDA Adverse Event
Malfunction
Summary report: N
INSIGNIA
MDR report key: 2170394
·
Received July 20, 2011
Report
- Report Number
- 2124215-2011-09718
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- June 2, 2011
- Report Date
- June 2, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- PMA / PMN Number
- D970003
- Product Problem
- 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 EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT PRESENTED TO TO THE HOSPITAL WITH PALPITATIONS. UPON INVESTIGATION, OVERSENSING WAS NOTED. THE PATIENT'S UNDERLYING RHYTHM CAME THROUGH AT 50 BPM. NO ADVERSE PATIENT EFFECTS WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | (B)(4)| 1194| (B)(4)| 1174 |