FDA Adverse Event
Death
Summary report: N
CONTAK RENEWAL 3 RF
MDR report key: 1210307
·
Received October 22, 2008
Report
- Report Number
- 2124215-2008-99958
- Event Type
- Death
- Date Received
- October 22, 2008
- Date of Event
- October 2, 2008
- Report Date
- October 21, 2008
- Manufacturer
- CLONMEL
- Product Code
- NIK
- Removal / Correction Number
- Z-0863-05
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NOT RETURNED. AT THIS TIME, NO ADDITIONAL INFO IS AVAILABLE. SHOULD ANY ADDITIONAL INFO RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT- D) MAY NOT HAVE PROVIDED APPROPRIATE SHOCK THERAPY TO PREVENT THE DEATH OF THIS PT. THE FOLLOWING PHYSICIAN WAS NOT CONTACTED FOR OFFICIAL CAUSE OF DEATH AS THIS PHYSICIAN IS THE DECEASED PT'S SON. THE DEVICE IN QUESTION, HAD BEEN BURIED WITH THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL 3 RF | IMPLANTABLE CHF GENERATOR | NIK | CLONMEL | H215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | 5068/LDJ048027V| H135/777850| 4513/400071| 0125/226288 |