FDA Adverse Event
Malfunction
Summary report: N
ACTIVE FIXATION ENDOCARDIAL LEAD
MDR report key: 3924208
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-15142
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- May 5, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR AN UNRELATED SCHEDULED PROCEDURE. THE ATRIAL LEADS INSULATION EXHIBITED AN ANOMALY AND WAS CAPPED AND REPLACED DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399885 | ACTIVE FIXATION ENDOCARDIAL LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, INC., CRMD | 1188T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | 1346T/58, (B)(4) |