FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 3052773
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-04785
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 1, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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 PHYSICIAN SAW AN ERROR CODE FOR SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS ON THE RIGHT VENTRICULAR (RV) LEAD WHILE TESTING THE DEVICE. DURING A REVISION PROCEDURE, IT WAS NOTED THE CONNECTION BETWEEN THE DEVICE AND LEAD WAS LOOSE. THE CONNECTOR OF THE LEAD WAS CLEANED AND RECONNECTED TO THE DEVICE. ALL TESTING WAS SUCCESSFUL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154946 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |