FDA Adverse Event
Injury
Summary report: N
QUARTET
MDR report key: 3923421
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14718
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- April 1, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- OJX
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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 PRESENTED FOR FOLLOW-UP AFTER RECEIVING A VIBRATORY ALERT. LOW IMPEDANCE, NOISE, AND AN UNSTABLE CAPTURE THRESHOLD WERE NOTED ON THE LEFT VENTRICULAR LEAD. ON (B)(6) 2014, LEAD REVISION OCCURRED. THE LEAD WAS DISCONNECTED AND REINSERTED INTO THE DEVICE AND IN-RANGE VALUES WERE OBSERVED. NO DAMAGE WAS SEEN AND THE PHYSICIAN OPTED TO CONTINUE USING THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399305 | QUARTET | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1458Q/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |