FDA Adverse Event
Malfunction
Summary report: N
ALTRUA
MDR report key: 2053178
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-03894
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 3, 2011
- Report Date
- March 8, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A RATE FAULT RESET COULD NOT BE EXPLAINED. -THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER WAS RETURNED FOR DISPOSAL AFTER EXPLANT. NO PRODUCT PERFORMANCE ALLEGATIONS OR ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED WITH REGARD TO THIS DEVICE. ROUTINE INITIAL RETURNED DEVICE TESTING INDICATED THAT DETAILED ANALYSIS WAS REQUIRED.
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 | 4469| 4456| S603| 1298 |