FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 1050391
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01377
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- December 18, 2007
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- 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 LEAD HAD VEGETATION ON IT AND WAS EXPLANTED. ONCE THE LEAD WAS OUT, DARK SPOTS WERE NOTED ON THE INSULATION WHERE IT APPEARED THAT BLOOD HAD ENTERED THE LEAD BODY. INSULATION BREACHES WERE NOTED NEAR THE ELECTRODES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1488T/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |