FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 2240290
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05830
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- July 21, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI
- 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 THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2011 DUE TO DIAPHRAGMATIC STIMULATION. THE PATIENT WAS DISCHARGED BUT RETURNED ON (B)(6) 2011 COMPLAINING OF CHEST PAIN. INTERMITTENT VENTRICULAR CAPTURE WAS NOTED. THE RIGHT VENTRICULAR LEAD HAD PERFORATED THE ANTERIOR FREE WALL. IT WAS SUSPECTED THAT LEAD DISLODGEMENT PRECEDED THE PERFORATION. THE LEAD WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2088TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention |