FDA Adverse Event
Death
Summary report: N
ATTAIN OTW
MDR report key: 1972006
·
Received January 27, 2011
Report
- Report Number
- 2649622-2011-00128
- Event Type
- Death
- Date Received
- January 27, 2011
- Date of Event
- April 4, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P010015/S012
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY ONE MONTH POST IMPLANT OF THE IMPLANTABLE CARDIAC DEFIBRILLATOR AND LEAD. THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME AND HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN OTW | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4194 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Death | 7120 COMPETITOR IMPLANTABLE TACHY LEAD |