FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
MDR report key: 4833660
·
Received June 10, 2015
Report
- Report Number
- 2183613-2015-00624
- Event Type
- Malfunction
- Date Received
- June 10, 2015
- Date of Event
- February 16, 2015
- Report Date
- March 13, 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: ANALYSIS FOUND ONE CONTROL KNOB BROKEN. ANALYSIS ALSO FOUND THE UPPER CASE, LOWER CASE, AND BAIL COVER WERE BROKEN. IT IS NOTED THE BAIL COVER, RING COVER, RING COVER SCREW, AND THE RING WERE MISSING. (B)(4).
Description of Event or Problem · 1
THE EXTERNAL PULSE GENERATOR WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378683 | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC MILACA, INC. | 5348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |