FDA Adverse Event
Death
Summary report: N
CAPSURE SP NOVUS
MDR report key: 3190627
·
Received June 26, 2013
Report
- Report Number
- 2649622-2013-08136
- Event Type
- Death
- Date Received
- June 26, 2013
- Date of Event
- March 3, 2013
- Report Date
- May 30, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- 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. CONCOMITANT PRODUCTS: D314DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED: (B)(6) 2013; 694758 IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT IS DECEASED AND DIED APPROXIMATELY SIX WEEKS AFTER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REPLACED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291514 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5592-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Death |