FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 2953490
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-01123
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 26, 2012
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED AND THE PATIENT HAD DIAPHRAGMATIC STIMULATION. ALSO, THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND THERE WAS POSSIBLE EARLY BATTERY DEPLETION. THE LV LEAD WAS REPOSITIONED AND REMAINS IN USE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57210 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00081 YR | Hospitalization| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |