FDA Adverse Event
Injury
Summary report: N
ISOFLEX S
MDR report key: 1896175
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04960
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- July 28, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2008 DUE TO CHEST PAIN; AUTOCAPTURE WAS TURNED OFF. ON (B)(6) 2010, THE PATIENT WAS ADMITTED WITH LOSS OF CAPTURE. ON (B)(6) 2010 THE PATIENT WAS ADMITTED WITH COMPLETE HEART BLOCK, BRADYCARDIA, CHEST PAIN AND LOSS OF CAPTURE. ALTHOUGH AN ECHOCARDIOGRAM DID NOT FIND LEAD FRACTURE, DAMAGE, DISLODGEMENT OR PERFORATION, THE LEAD WAS CAPPED AND REPLACED. INCREASED SCAR TISSUE WAS OBSERVED AT THE ORIGINAL IMPLANT SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOFLEX S | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1646T/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |