FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 2780168
·
Received October 10, 2012
Report
- Report Number
- 2124215-2012-12147
- Event Type
- Injury
- Date Received
- October 10, 2012
- Date of Event
- September 2, 2012
- Report Date
- September 3, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OUR RECORDS INDICATE THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PACEMAKER HAD BEEN TRAVELING BY AIRPLANE. WHEN THE PATIENT GOT ON THE PLANE, SHE PASSED OUT FOR APPROXIMATELY ONE HOUR. THE PATIENT ALSO MENTIONED HAVING DIFFICULTY BREATHING. WHEN THE PATIENT WOKE UP, SHE INDICATED SHE FELT NORMAL. IT WAS NOTED THAT THE PATIENT HAD TRAVELED BY AIRPLANE PREVIOUSLY AND HAD NO ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTRUA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | S603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Life Threatening | 4136| S603| 4135 |