FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 3211334
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08456
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- May 15, 2013
- Report Date
- May 15, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE VENTRICULAR TACHYCARDIA (VT) RATE CUTOFF WILL BE REPROGRAMMED TO MITIGATE THE INAPPROPRIATE SHOCKS. RECORDS INDICATE THIS DEVICE REMAINS IN SERVICE. 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) RECEIVED NUMEROUS INAPPROPRIATE SHOCKS FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) WHICH EXHAUSTED THERAPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309518 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | 0158| 4136| E110 |