FDA Adverse Event
Malfunction
Summary report: N
REPLY
MDR report key: 6144239
·
Received December 5, 2016
Report
- Report Number
- 1000165971-2016-00783
- Event Type
- Malfunction
- Date Received
- December 5, 2016
- Date of Event
- November 3, 2016
- Report Date
- November 16, 2016
- Manufacturer
- SORIN GROUP ITALIA S.R.L. - CRM FACILITY
- Product Code
- DTB
- PMA / PMN Number
- P950029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PRELIMINARY ANALYSIS DID NOT REVEAL ANY DEVICE MALFUNCTION.
Description of Event or Problem · 1
REPORTEDLY, THE REMAINING LONGEVITY UNEXPECTEDLY DECREASED BETWEEN TWO FOLLOW-UPS.
Description of Event or Problem · 1
REPORTEDLY, THE REMAINING LONGEVITY UNEXPECTEDLY DECREASED BETWEEN TWO FOLLOW-UPS.
Description of Event or Problem · 1
REPORTEDLY, THE REMAINING LONGEVITY UNEXPECTEDLY DECREASED BETWEEN TWO FOLLOW-UPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 795796 | REPLY | PULSE GENERATOR, PERMANENT, IMPLANTABLE | DTB | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | REPLY DR | 2466 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |