FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 1946184
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-20623
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- July 8, 2010
- Report Date
- October 15, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- PMA / PMN Number
- P960040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
INFORMATION SUGGESTED BOTH PRODUCTS REMAINED IN-SERVICE. INVESTIGATION WAS COMPLETED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT RIGHT ATRIAL IMPEDANCES FROM A NON-BOSTON SCIENTIFIC LEAD HAD BEEN FLUCTUATING BETWEEN 1100 OHMS AND 400-500 OHMS. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | 7278| 6947| E110| 5568 |