FDA Adverse Event
Injury
Summary report: N
ATTAIN LV
MDR report key: 2964399
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-02025
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- January 10, 2007
- Report Date
- December 11, 2012
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) DISLODGED. THE LEAD WAS REPOSITIONED AND REMAINED IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66951 | ATTAIN LV | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 2187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00086 YR | Hospitalization| R |