FDA Adverse Event
Injury
Summary report: N
CURRENT DR RF
MDR report key: 4173882
·
Received October 15, 2014
Report
- Report Number
- 2938836-2014-16690
- Event Type
- Injury
- Date Received
- October 15, 2014
- Date of Event
- September 10, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 THE PATIENT RECEIVED INAPPROPRIATE THERAPY DURING AN OPEN HEART PROCEDURE. A MAGNET WAS NOT USED DURING THE OPERATION. A TEMPORARY EPICARDIAL PACEMAKER WAS PLACED AND HAD OVERSENSED ON THE VENTRICULAR CHANNEL. WHEN THE EXTERNAL PACEMAKER WAS TURNED OFF, THE SHOCKS STOPPED. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS STABLE AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654550 | CURRENT DR RF | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | 2207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |