FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
MDR report key: 3152018
·
Received June 7, 2013
Report
- Report Number
- 2183613-2013-00533
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- March 25, 2013
- Report Date
- March 25, 2013
- Manufacturer
- MEDTRONIC MILACA, INC.
- Product Code
- LWP
- PMA / PMN Number
- P820003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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. (B)(6). (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; LCD (LIQUID CRYSTAL DISPLAY) IS OUT OF ELECTRICAL SPECIFICATION (MISSING PIXELS).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING INSPECTION OF THE EXTERNAL PULSE GENERATOR IT WAS DISCOVERED THAT THERE WERE MISSING SEGMENTS IN THE LOWER DISPLAY. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252520 | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC MILACA, INC. | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |