FDA Adverse Event
Death
Summary report: N
ATTAIN
MDR report key: 2844813
·
Received November 26, 2012
Report
- Report Number
- 2649622-2012-17471
- Event Type
- Death
- Date Received
- November 26, 2012
- Date of Event
- October 18, 2012
- Report Date
- October 30, 2012
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. FOR USE BY USER FACILITY/IMPORTER(DEVICES ONLY). (B)(4). IMPLANTABLE PACING LEAD 2012 (B)(6), IMPLANTABLE CARDIAC DEFIBRILLATOR 2012 (B)(6). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT IS DECEASED AND DIED THREE DAYS POST IMPLANT OF IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 4196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Death |