FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
MDR report key: 3153526
·
Received June 8, 2013
Report
- Report Number
- 2183613-2013-00613
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Report Date
- March 13, 2013
- Manufacturer
- MEDTRONIC MILACA, INC.
- Product Code
- LWP
- PMA / PMN Number
- P820003
- 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 THAT THE UPPER AND LOWER CASES WERE BROKEN, THE RING COVER WAS CONTAMINATED, THE SIDE BAIL COVERS WERE BROKEN AND THE VENTRICULAR OUTPUT CONNECTOR WAS BROKEN. (B)(4).
Additional Manufacturer Narrative · 1
FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. (B)(4).
Description of Event or Problem · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR TESTING AND CALIBRATION. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256713 | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC MILACA, INC. | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |