FDA Adverse Event
Malfunction
Summary report: N
SOLUS
MDR report key: 152639
·
Received February 6, 1998
Report
- Report Number
- 2017865-1998-00059
- Event Type
- Malfunction
- Date Received
- February 6, 1998
- Date of Event
- August 5, 1997
- Report Date
- September 30, 1997
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
INFORMATION RECEIVED REGARDING THE DEVICE DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES THAT THE DEVICE HAD GONE I NTO MICROPROCESSOR RESET CONDITIONS MULTIPLE TIMES SINCE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLUS Implant | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2002L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |