FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 3213095
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10615
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 5, 2013
- Report Date
- June 6, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
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.
Additional Manufacturer Narrative · 1
--
Description of Event or Problem · 1
--
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING EQUIPMENT DETECTED A HIGH OUT OF RANGE SHOCKING IMPEDANCE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. IT WAS DETERMINED THAT THE PATIENT WAS UNDERGOING A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) PROCEDURE DURING THE TIME OF THE OUT-OF-RANGE (OOR) MEASUREMENT. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314415 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | 0185| 4470| E110 |