FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 1861147
·
Received October 8, 2010
Report
- Report Number
- 2124215-2010-15669
- Event Type
- Injury
- Date Received
- October 8, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 28, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
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 PACEMAKER WAS EXPLANTED DUE TO INFECTION. 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 | 85 YR | Life Threatening| R | MISMATCH| S603 |