FDA Adverse Event
Death
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3163191
·
Received June 11, 2013
Report
- Report Number
- 2649622-2013-08070
- Event Type
- Death
- Date Received
- June 11, 2013
- Date of Event
- May 9, 2013
- Report Date
- September 11, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- 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.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS RETURNED FROM THE (B)(6) MEDICAL EXAMINER OFFICE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE PAPERWORK INDICATED THE PATIENT DIED APPROXIMATELY EIGHT MONTHS POST IMPLANT OF THE CRT-D SYSTEM APPROXIMATELY THREE YEARS AGO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264142 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Death |