FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 3040681
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-01478
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- January 8, 2013
- Report Date
- January 8, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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 THROUGH A REMOTE MONITORING SYSTEM THAT THIS DEVICE DETECTED AN OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. REVIEW OF THE DEVICE INFORMATION INDICATED NORMAL SHOCK LEAD VARIATION BETWEEN 90 AND 120 OHMS WITH THE OCCASIONAL MEASUREMENT GREATER THAN 125 OHMS. NO LEAD FRACTURE WAS SUSPECTED; THEREFORE, THE PATIENT WILL BE FOLLOWED APPROPRIATELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143624 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | F102| 0128| 0148 |