TRANSVENE RV
Report
- Report Number
- 2182208-2014-01737
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- April 26, 2014
- Report Date
- April 29, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 4592-53 LEAD, IMPLANTED (B)(6) 2001; 418985 LEAD, IMPLANTED (B)(6) 2001. (B)(4).
PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE LV (LEFT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. SOME IMPEDANCES NOT MEASURED; LV TIP TO RING AND TIP TO COIL ARE UNDEFINED.
IT WAS REPORTED THAT A TRANSMISSION OBSERVED THE RIGHT VENTRICULAR (RV) LEAD HAD OVERSENSING. THE RV LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD MEASURED HIGH IMPEDANCE. THE LV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340674 | TRANSVENE RV | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC, INC. | 693675 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00078 YR | D224TRK ICD |