FDA Adverse Event
Injury
Summary report: N
FORTIFY DR, U1.6 DF1 ID
MDR report key: 4863929
·
Received June 23, 2015
Report
- Report Number
- 2938836-2015-27360
- Event Type
- Injury
- Date Received
- June 23, 2015
- Date of Event
- May 15, 2015
- Report Date
- May 15, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED INDICATED THAT PATIENT RECEIVED INAPPROPRIATE ANTITACHYCARDIA PACING DUE TO A SINGLE UNDERSENSED R-WAVE. PROGRAMMING CHANGES WERE MADE. PATIENT WAS IN STABLE CONDITION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC AND UPON INTERROGATION, IT WAS OBSERVED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY FOR SUPRAVENTRICULAR TACHYCARDIA THAT WAS MISDIAGNOSED AS VENTRICULAR TACHYCARDIA AS A RESULT OF AN UNDERSENSED R-WAVE. PROGRAMMING CHANGES WILL BE MADE IN-CLINIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 404844 | FORTIFY DR, U1.6 DF1 ID | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2233-40 | 3369305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |