FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 2240142
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05609
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- July 14, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT ABOUT ONE HOUR POST PACEMAKER CHANGE- OUT, THE PATIENT RETURNED TO THE OPERATING ROOM DUE TO PASS- ING OUT AND BRADYCARDIA BELOW 30 BPM. WHILE OPENING THE POCKET ALL PACING WAS LOST. FLUOROSCOPY REVEALED ATRIAL LEAD DISLODGEMENT. THE LEAD WAS REMOVED AND REPLACED. NO ADDITIONAL COMPLICATIONS OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1782TC/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | (B)(4) |