FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL PULSE GENERATOR
MDR report key: 2811730
·
Received October 31, 2012
Report
- Report Number
- 2183613-2012-01878
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- September 23, 2012
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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.
Description of Event or Problem · 1
THE BIOMEDICAL ENGINEER (BE) REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD A CRACKED LIQUID CRYSTAL DISPLAY (LCD) LENSE. THEREFORE, THE BE REQUESTED REPLACEMENT PART NUMBERS FOR THE EPG. TECHNICAL SUPPORT (TS) PROVIDED THE PART NUMBERS AND EXPLAINED TO THE BE THAT THE EPG MAY HAVE TO BE RETURNED FOR REPAIR IF THE REPLACEMENT PARTS ARE NOT SOLD. TS PROVIDED THE SERVICE DEPARTMENT ADDRESS AND FLAT RATE OF REPAIR. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTERNAL PULSE GENERATOR | DTE | MEDTRONIC MILACA INC. | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |