FDA Adverse Event
Malfunction
Summary report: N
2124215-2011-01128
MDR report key: 2040800
·
Received April 6, 2011
Report
- Report Number
- 2124215-2011-01128
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- January 17, 2009
- Report Date
- January 10, 2011
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIC RECEIVED INFORMATION THAT THIS DEVICE, IMPLANTED WITH ANOTHER MANUFACTURER'S RIGHT ATRIAL LEAD, EXHIBITED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE POCKET WAS REOPENED AND THE LEAD WAS RECONNECTED TO THE DEVICE. ACCEPTABLE MEASUREMENTS WERE THEN OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LWS | GUIDANT PUERTO RICO BV | TACHY DEVICE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |