FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL PULSE GENERATOR
MDR report key: 2791507
·
Received October 15, 2012
Report
- Report Number
- 2183613-2012-01727
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Date of Event
- July 17, 2012
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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 COULD NOT CONFIRM THE REPORTED EVENT. UPPER AND LOWER CASES, SIDE BAIL COVERS, AND RING COVER ARE BROKEN. BATTERY DRAWER IS STARTING TO DETACH. KEYBOARD IS SCRATCHED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR DISPLAYED AN ERROR MESSAGE DURING ITS SELF TEST. IT WAS RETURNED FOR SERVICE. IT WAS INDICATED ON THE RETURN PAPERWORK THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.
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 |