FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 4131464
·
Received October 1, 2014
Report
- Report Number
- 2124215-2014-14037
- Event Type
- Injury
- Date Received
- October 1, 2014
- Date of Event
- July 1, 2014
- Report Date
- July 1, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPORTED FEELING LIGHTHEADED AND PASSING OUT. THE FIELD REPRESENTATIVE IS UNAWARE OF ANY ISSUES WITH THIS DEVICE OR PATIENT. THERE ARE NO ADDITIONAL ADVERSE PATIENT EFFECTS KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 610462 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWP | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Life Threatening | 0184| E110| 1296| 4457| 4470 |