FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 3210384
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08170
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 16, 2013
- Report Date
- April 16, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD ENDOCARDITIS, AN INFECTION AND FULL BODY SEPSIS. THE PATIENT'S ENTIRE SYSTEM WAS EXPLANTED. THIS DEVICE WAS TEMPORARILY USED AS AN EXTERNAL PACEMAKER AND WAS INTERFACED TO A LEAD INSERTED IN THE PATIENT'S JUGULAR VEIN. A NEW SYSTEM WILL BE IMPLANTED AFTER THE PATIENT RECEIVES ANTIBIOTICS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311221 | ALTRUA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | S602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization| L | 430-02| 438-01| 4456| 4136| 1273| 284-05| 4135| S602 |