FDA Adverse Event
Malfunction
Summary report: N
ATTAIN OTW
MDR report key: 3992402
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09868
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 29, 2014
- Report Date
- May 29, 2014
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCTS: (B)(4) ICD IMPLANTED: 2011 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ALERT TRIGGERED FOR HIGH LEFT VENTRICULAR (LV) LEAD IMPEDANCES. THE PATIENT WAS SEEN IN CLINIC AND THE CLINIC REPORTED "EVERYTHING IS NORMAL." THE LEAD REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472504 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 4193 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6947-65 LEAD |