FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL PULSE GENERATOR
MDR report key: 2812006
·
Received October 31, 2012
Report
- Report Number
- 2183613-2012-01879
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 8, 2012
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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
IT WAS REPORTED THAT DURING ROUTINE PREVENTATIVE MAINTENANCE OF THE EXTERNAL PULSE GENERATOR (EPG), THE BIOMEDICAL ENGINEER (BE) OBSERVED THAT WHEN THE TEST LEADS WERE PUT INTO THE PATIENT CONNECTOR, THE CONNECTION WAS "A BIT SLOPPY." TECHNICAL SUPPORT (TS) HAD THE BE SEPARATE LOWER AND UPPER CASE, LOOK AT THE OUTPUT CIRCUIT, REMOVE PATIENT CONNECTOR, AND CHECK PINS. THE PINS WERE CLEAN; THEREFORE, HAD THE CALLER PINCH METAL CLIPS AND THE ISSUE WAS RESOLVED. THE EPG REMAINS IN USE. 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 |