FDA Adverse Event
Malfunction
Summary report: N
CARDIA VR
MDR report key: 4160085
·
Received October 10, 2014
Report
- Report Number
- 9614453-2014-02398
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- July 24, 2014
- Report Date
- July 24, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN CONDUCTING INITIAL IMPLANTABLE PULSE GENERATOR (IPG) TESTING AT THE START OF THE PROCEDURE, THE CHARGE TIME WAS LONGER THAN EXPECTED/EXCEEDED THE EXPECTED CHARGE TIME. THE IPG WAS EXCHANGED FOR ANOTHER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 637605 | CARDIA VR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | IPG MFG SWITZERLAND | D384VRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00046 YR |