FDA Adverse Event
Death
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2880666
·
Received December 19, 2012
Report
- Report Number
- 2649622-2012-18286
- Event Type
- Death
- Date Received
- December 19, 2012
- Date of Event
- November 16, 2012
- Report Date
- February 4, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039/S017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED LESS THAN ONE YEAR AFTER IMPLANT. THE PATIENT WAS 11 MONTHS POST HEART TRANSPLANT. NO KNOWN COMPLAINTS OR MALFUNCTIONS WITH THE DEVICE SYSTEM. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT YET MADE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR | Death |