FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 2060023
·
Received April 15, 2011
Report
- Report Number
- 2124215-2011-06042
- Event Type
- Injury
- Date Received
- April 15, 2011
- Date of Event
- March 30, 2011
- Report Date
- March 30, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE AND LEAD REMAIN IN SERVICE. 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 THIS PACEMAKER AND RIGHT VENTRICULAR PACING LEAD EXHIBITED INCREASED THRESHOLD MEASUREMENTS. AUTOMATIC CAPTURE HAD BEEN PROGRAMMED ON AT A PREVIOUS DEVICE CHECK. UPON INTERROGATION THE DEVICE WAS FOUND TO BE IN RETRY AT 3.5V AT .4 MS. A STORED EPISODE REVEALED LOSS OF CAPTURED WITH ASYSTOLE FOR 2.1 SECONDS. THE PATIENT HAS BEEN EXPERIENCING SHORTNESS OF BREATH AND FATIGUE. OUTPUTS WERE REPROGRAMMED TO 6.5 V AT 1.0 MS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTRUA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | S601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Life Threatening | 4470| S601 |