FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 1952791
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-24569
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 7, 2010
- Report Date
- December 7, 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
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT PRESENTED TO THE CLINIC WITH COMPLAINTS OF SYNCOPE FOR AN UNKNOWN REASON. UPON INTERROGATION THE PHYSICIAN NOTED NO IRREGULARITIES AND ISOMETRICS ALONG WITH POCKET MANIPULATION WERE UNABLE TO PRODUCE ANY ISSUES. THE PHYSICIAN STATED THAT HE BELIEVES THE EPISODES MIGHT BE DUE TO LOW BLOOD PRESSURE AND DEHYDRATION. NO ADDITIONAL 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 | 76 YR | Life Threatening | 4480| 4457| S603 |