FDA Adverse Event
Injury
Summary report: N
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
MDR report key: 4133712
·
Received October 1, 2014
Report
- Report Number
- 2938836-2014-16275
- Event Type
- Injury
- Date Received
- October 1, 2014
- Date of Event
- August 1, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MERLIN.NET TRANSMISSION REVEALED THAT THE PATIENT RECEIVED INAPPROPRIATE ATP THERAPY DUE TO NOISE. THE PATIENT REPORTED THAT HE WAS USING AN ELECTRIC RAZOR AT THE TIME WITH MALFUNCTIONED AND BEGAN SPARKING. REVIEW OF THE EGMS REVEALED OVERSENSING OF NON-PHYSIOLOGICAL SIGNALS POSSIBLY ASSOCIATED TO EMI. THE PATIENT WAS BROUGHT IN FOR EVALUATION AND THE NOISE WAS NOT REPRODUCED WITH ISOMETRICS. THE PATIENT WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 610892 | QUADRA ASSURA CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3265-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |