FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
MDR report key: 4831558
·
Received June 10, 2015
Report
- Report Number
- 2183613-2015-00494
- Event Type
- Malfunction
- Date Received
- June 10, 2015
- Date of Event
- March 20, 2015
- Report Date
- April 23, 2015
- Manufacturer
- MEDTRONIC MILACA, INC.
- Product Code
- LWP
- PMA / PMN Number
- P820003
- Removal / Correction Number
- Z-1661-2014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: DURING ANALYSIS THE DEVICE FAILED AN INCOMING VXI TEST DUE TO INTERMITTENT OPERATION. IT WAS FURTHER NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN. THE DEVICE WAS TO BE SCRAPPED IN-HOUSE. (B)(4).
Description of Event or Problem · 1
THE EXTERNAL PULSE GENERATOR WAS RETURNED AS A TRADE-IN AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378485 | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC MILACA, INC. | 5348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |