FDA Adverse Event
Injury
Summary report: N
INTEGRITY SR
MDR report key: 1073050
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-01986
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 3, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
DURING INTERROGATION THE PULSE GENERATOR EXHIBITED LOSS OF VENTRICULAR CAPTURE AT HIGH OUTPUTS IN BOTH CONFIGURATIONS. ISOMETRICS AND POCKET MANIPULATION DID NOT REVEAL ANY NOISE OR INHIBITION. THE PULSE GENERATOR WAS SUBSEQUENTLY RE- PLACED. THE PATIENT WOULD BE MONITORED CLINICALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRITY SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5142 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |