FDA Adverse Event
Malfunction
Summary report: N
ANTHEM RF
MDR report key: 3925903
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15692
- Event Type
- Malfunction
- Date Received
- July 10, 2014
- Date of Event
- April 17, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- 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 IMPLANT OF THE PULSE GENERATOR, RADIO FREQUENCY COULD NOT BE ESTABLISHED. INDUCTIVE INTERROGATION REVEALED A PREMATURE END OF LIFE INDICATOR. ELECTROCAUTERY HAD BEEN USED DURING THE PROCEDURE AND PRIOR TO THE EVENT. A FIRMWARE DOWNLOAD RESTORED THE DEVICE TO NORMAL FUNCTIONALITY. THE PULSE GENERATOR WAS SUCCESSFULLY IMPLANTED AND THE PATIENT WOULD BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 402771 | ANTHEM RF | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM3210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |