FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL PULSE GENERATOR
MDR report key: 2812286
·
Received October 31, 2012
Report
- Report Number
- 2183613-2012-01844
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- September 19, 2012
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
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. THE VENTRICULAR OUTPUT CONNECTOR WAS MECHANICALLY OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT ONE BAIL COVER AND THE LEAD FLEX COVER WERE BROKEN, THE LEAD FLEX O-RING WAS DAMAGED, AND THE KEYBOARD WAS SCRATCHED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE TESTING THE EPG (EXTERNAL PULSE GENERATOR) PRIOR TO USE, THERE WAS NO OUTPUT ON THE VENTRICULAR SIDE. THE EPG WAS RETURNED FOR 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 |