FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 1871198
·
Received October 15, 2010
Report
- Report Number
- 2124215-2010-18172
- Event Type
- Injury
- Date Received
- October 15, 2010
- Date of Event
- February 1, 2010
- Report Date
- August 24, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- PMA / PMN Number
- P960040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
A LEAD REVISION PROCEDURE WAS SCHEDULED. ATTEMPTS TO IDENTIFY HOW THIS WAS RESOLVED HAVE BEEN UNSUCCESSFUL.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES. 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 | 78 YR | Required Intervention | 1861| E110| 0148| 4469 |