FDA Adverse Event
Injury
Summary report: N
ACTIVE FIXATION LEAD
MDR report key: 3923227
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14525
- Event Type
- Injury
- Date Received
- July 9, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- 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 RIGHT VENTRICULAR LEAD HAD DISLODGED. A PARTIAL LEAD WAS REMOVED IN 1998 AND THE REMAINING LEAD WAS EXPLANTED ON (B)(6) 2014. THE DISTAL TIP AND RING ELECTRODE SEPARATED AND WERE LEFT IN THE RIGHT VENTRICLES APEX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401985 | ACTIVE FIXATION LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, INC., CRMD | 1146T/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |