FDA Adverse Event
Injury
Summary report: N
BI,TINED,VS-1,ENDO LEAD
MDR report key: 5644043
·
Received May 10, 2016
Report
- Report Number
- 2017865-2016-02929
- Event Type
- Injury
- Date Received
- May 10, 2016
- Date of Event
- March 12, 2016
- Report Date
- March 17, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- DTB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PLEASE NOTE THE CORRECTION FOR REFERENCE REPORT NUMBER 2017865-2016-02929. EXPIRATION DATE SHOULD BE APRIL 1, 1995; NOT BLANK. MANUFACTURE DATE SHOULD BE APRIL 21, 1993; NOT BLANK.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED ON (B)(6) 2016 DUE TO OVERSENSING. NO PATIENT SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299847 | BI,TINED,VS-1,ENDO LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1226T/60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |