FDA Adverse Event
Injury
Summary report: N
REGENCY SC
MDR report key: 1073398
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02187
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 7, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- P880006
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE PULSE GENERATOR EXHIBITED LOSS OF OUTPUT DUE TO A DEPLETED BATTERY. THE PREMATURE BATTERY DEPLETION WAS CAUSED BY INTERMITTENT HIGH CURRENT DRAIN, DUE TO AN INTEGRATED CIRCUIT ANOMALY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED LOSS OF VENTRICULAR CAPTURE.
Description of Event or Problem · 1
CUSTOMER REPORTS LANCET DID NOT RETRACT INTO MULTICLIX DEVICE AFTER FIRING, LANCET IS PROTRUDING FROM DEVICE CAP. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE PRODUCT, REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REGENCY SC | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2406L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |