FDA Adverse Event
Injury
Summary report: N
PROMOTE ACCEL CRT-D, DF-4 CONNECTOR
MDR report key: 4221025
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17430
- Event Type
- Injury
- Date Received
- November 3, 2014
- Date of Event
- August 28, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED PATIENT NOTIFIER ANOMALY WAS CONFIRMED IN THE LABORATORY. AN ANOMALOUS PATIENT NOTIFIER WHICH DID NOT VIBRATE WAS CONFIRMED DURING BENCH TESTING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT NOTIFIER WAS NOT RESPONSIVE DURING TESTING AND THE PATIENT DID NOT FEEL IT. IT WAS RECOMMENDED TO MONITOR THE PATIENT FOR ERI TRIP VIA MERLIN.NET INSTEAD.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702277 | PROMOTE ACCEL CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3215-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |