FDA Adverse Event
Malfunction
Summary report: N
MERLIN PROGRAMMER
MDR report key: 6079671
·
Received November 4, 2016
Report
- Report Number
- 2938836-2016-13814
- Event Type
- Malfunction
- Date Received
- November 4, 2016
- Date of Event
- September 14, 2016
- Report Date
- September 14, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- KRG
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MERLIN PROGRAMMER ESTIMATED BATTERY LONGEVITY INCORRECTLY. THE LIVE OF THE BATTERY WAS ESTIMATED LONGER THAT IT WAS SUPPOSED TO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 731224 | MERLIN PROGRAMMER | PACEMAKER PROGRAMMER | KRG | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 3650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |