FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
MDR report key: 4833701
·
Received June 10, 2015
Report
- Report Number
- 2182208-2015-02019
- Event Type
- Malfunction
- Date Received
- June 10, 2015
- Date of Event
- March 4, 2015
- Report Date
- April 2, 2015
- Manufacturer
- MEDTRONIC, 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 INCOMING VXI TESTING, STEP 1008 20 MILLIVOLT SENSITIVITY. THE FAILURE WAS RERUN 10 TIMES AND IT PASSED AND THEREFORE IT WAS NOTED THAT THE DEVICE HAD INTERMITTENT OPERATION. ANALYSIS FURTHER NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN. (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 |
|---|---|---|---|---|---|---|---|
| 379070 | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC, INC. | 5348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |