FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 2163312
·
Received July 15, 2011
Report
- Report Number
- 2124215-2011-08410
- Event Type
- Injury
- Date Received
- July 15, 2011
- Date of Event
- April 22, 2011
- Report Date
- April 22, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- PMA / PMN Number
- D970003/S106
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD EXPERIENCED A SYNCOPAL EPISODE. THE CALLER WAS INQUIRING ABOUT PROGRAMMING FOR SUDDEN BRADY RESPONSE (SBR) DEVICE FEATURE. THE PHYSICIAN ASSISTANT ASSOCIATED WITH THIS PRODUCT ISSUE WAS CONVINCED THE PATIENT'S SYNCOPAL EPISODE WAS RELATED TO DEHYDRATION AFTER SHE EXPLAINED THE PROCESS LEADING UP TO THE EVENT. ADDITIONALLY, DEVICE INTERROGATION WAS NORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTRUA | NVZ | GUIDANT CRM CLONMEL IRELAND | S606 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | S606| 4087| 4086 |