FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL PULSE GENERATOR
MDR report key: 2810459
·
Received October 31, 2012
Report
- Report Number
- 2182208-2012-03678
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- September 5, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE REPORTED EVENT. LCD (LIQUID CRYSTAL DISPLAY) IS MISSING PIXELS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LOWER DISPLAY OF THE EXTERNAL PULSE GENERATOR WAS MISSING SEGMENTS. IT WAS FURTHER NOTED THAT SEGMENTS WERE MISSING BOTH VERTICALLY AND HORIZONTALLY. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED ON THE RETURN PAPERWORK THAT THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTERNAL PULSE GENERATOR | DTE | MEDTRONIC, INC. | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |