FDA Adverse Event
Death
Summary report: N
ATTAIN OTW
MDR report key: 2962383
·
Received February 14, 2013
Report
- Report Number
- 2649622-2013-02434
- Event Type
- Death
- Date Received
- February 14, 2013
- Date of Event
- November 16, 2012
- Report Date
- January 17, 2013
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 BY A FAMILY MEMBER THE PATIENT HEARD AN "ALERT TONE PLAYING RECENTLY AND WONDERED WHAT IT WAS FOR." FOLLOW-UP WITH THE PHYSICIAN WAS RECOMMENDED. ADDITIONAL INFORMATION FROM THE PHYSICIAN'S OFFICE INDICATED THE PATIENT IS DECEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65512 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00085 YR | Death | 5076-45 IMPLANTABLE PACING LEAD |