FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 3220209
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04324
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- December 12, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- 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
(B)(6).
Additional Manufacturer Narrative · 1
FOLLOWING FIELDS DELETED: USER CLASSIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT PRESENTED TO THE CLINIC WITH SUSPECTED LEAD ISSUES. EVALUATION OF THE LEAD REVEALED MULTIPLE NOISE ANOMALIES AND INCREASED THRESHOLDS. IT WAS LATER NOTED THAT THE ACTIVE FIXATION SCREW WAS IN THE DIAPHRAGM. NOISE WAS REPRODUCIBLE WHEN THE PATIENT TOOK DEEP BREATHS. THE LEAD REMAINS IMPLANTED. NOR FURTHER INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED STATES THE LEAD WA S CAPPED AND REPLACED. LEAD FRACTURE WAS NOTED. THE PATIENT CONDITION WAS FINE DURING AND AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320884 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7121/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |