FDA Adverse Event
Injury
Summary report: N
TENDRIL DX
MDR report key: 1222971
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03250
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 12, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT CALLED HER PHYSICAN BECAUSE SHE HAD PASSED OUT AND WAS FEELING BAD. A PHONE CHECK WAS PERFORMED AND SHOWED NOTHING ABNORMAL. THE FOLLOWING MORNING, THE PATIENT PASSED OUT AGAIN AND WAS TAKEN TO THE EMERGENCY ROOM. HER HEART RATE WAS 20 BEATS PER MINUTE, UPON ARRIVAL. THE POCKET WAS OPENED FOR A LEAD REVISION, AND LEAD FRACTURE DUE TO CLAVICULAR CRUSH WAS NOTED. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL DX | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1388T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |