FDA Adverse Event
Injury
Summary report: N
PROMOTE PLUS CRT-D, DF-4 CONNECTOR
MDR report key: 2243077
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06573
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- July 26, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- 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.
Additional Manufacturer Narrative · 1
THE REPORTED SETSCREW ANOMALY WAS CONFIRMED IN THE LABORATORY. UPON RECEIPT DAMAGE TO THE ATRIAL SEPTUM WAS OBSERVED. TEST LEADS WERE INSERTED INTO THE DEVICE HEADER AND THE ATRIAL SETSCREW WOULD NOT TIGHTEN TO FULL TORQUE. SEPTUM MATERIAL WAS FOUND INSIDE OF THE HEX CAVITY AND ONCE REMOVED THE ATRIAL SETSCREW FUNCTIONED NORMALLY. THE SETSCREW ANOMALY CONTRIBUTED TO A POOR SETSCREW/LEAD CONNECTION, CAUSING HIGH PACING LEAD IMPEDANCE AND LOSS OF SENSING AND CAPTURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT INCREASED IMPEDANCE WITH A LOSS OF SENSING AND CAPTURE WERE OBSERVED. SETSCREW ISSUE WAS FOUND. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROMOTE PLUS CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |