FDA Adverse Event
Injury
Summary report: N
CURRENT DR RF
MDR report key: 4220925
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17411
- Event Type
- Injury
- Date Received
- November 3, 2014
- Date of Event
- May 5, 2009
- 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
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
LEGAL CONSULT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD RECEIVED INAPPROPRIATE THERAPIES TWO DIFFERENT TIMES FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE PATIENTS MEDICATIONS WERE ADJUSTED FOR THE FIRST EVENT. AFTER THE SECOND EVENT IN 2012, THE PATIENT WAS SCHEDULED FOR AN AV NODE ABLATION AND UPGRADED TO A BI-V ICD SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703441 | CURRENT DR RF | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | 2207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |