FDA Adverse Event
Malfunction
Summary report: N
PROMOTE RF CRT-D
MDR report key: 4153521
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16495
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 10, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE INTERROGATION, ONE OCCURRENCE OF T-WAVE OVERSENSING AFTER PSEUDOFUSION BEAT WAS OBSERVED. PROGRAMMING OPTIONS WERE RECOMMENDED. A LONGEVITY CALCULATION WAS PERFORMED AND THE DEVICE WAS FOUND NOT TO BE WITHIN LONGEVITY ESTIMATIONS. THE PHYSICIAN HAS DECIDED TO TAKE NO ACTION. DEVICE REMAINS IMPLANTED. PATIENT CONDITION IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632090 | PROMOTE RF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | 3213-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |