FDA Adverse Event
Death
Summary report: N
CAPSURE SENSE
MDR report key: 3002906
·
Received March 13, 2013
Report
- Report Number
- 2649622-2013-02527
- Event Type
- Death
- Date Received
- March 13, 2013
- Date of Event
- August 28, 2011
- Report Date
- June 18, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: (B)(4) - THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND, VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED ONLY.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER REVEALED THE PATIENT TO BE DECEASED APPROXIMATELY 5 DAYS AFTER IMPLANT. FOLLOW UP WAS DONE WITH ALL REASONABLE CONTACTS AND ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET MADE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104810 | CAPSURE SENSE | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 457445 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00067 YR | Death |