FDA Adverse Event
Injury
Summary report: N
CONFIRM
MDR report key: 4171604
·
Received October 14, 2014
Report
- Report Number
- 2017865-2014-17612
- Event Type
- Injury
- Date Received
- October 14, 2014
- Date of Event
- April 4, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- MXC
- PMA / PMN Number
- K081365
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. BASED ON RECORD REVIEW, IT WAS DETERMINED THAT THIS RECORD HAD NOT PREVIOUSLY BEEN FILED AS AN MDR. (B)(4). FINAL ANALYSIS FOUND A BATTERY ANOMALY HAD CONTRIBUTED TO THE REPORTED ANOMALIES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL EXPERIENCING SYNCOPE. THE PHYSICIAN ATTEMPTED TO INTERROGATE THE IMPLANTABLE CARDIAC MONITOR AND AN ERROR MESSAGE WAS DISPLAYED. THE DEVICE EXHIBITED THE SAME RESULTS WITH FOUR OTHER PROGRAMMERS. THE PATIENT HAD BEEN LOST TO FOLLOW UP. THE DEVICE WAS EXPLANTED ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650058 | CONFIRM | IMPLANTABLE CARDIAC MONITOR | MXC | ST. JUDE MEDICAL, INC., CRMD | DM2100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |