FDA Adverse Event
Malfunction
Summary report: N
INPUT INTRODUCER (UNK)
MDR report key: 2053384
·
Received March 16, 2011
Report
- Report Number
- 1220452-2011-00018
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- February 17, 2011
- Report Date
- February 17, 2011
- Manufacturer
- MEDTRONIC INC.
- Product Code
- DYB
- PMA / PMN Number
- K940092
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER HAS INDICATED THAT THE SUBJECT DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVAL. THEREFORE, AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT DETECT ANY DEFICIENCIES IN THE MFG PROCESS. DEVICE DISCARDED-NOT RETURNED FOR EVAL. THE EVENT HAS NOT BEEN CONFIRMED; NO PRODUCT WAS RETURNED FOR EVAL.
Description of Event or Problem · 1
IT HAS BEEN REPORTED TO US THE PT HAD AN ADVERSE REACTION DURING A PROCEDURE. NO ADD'L INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INPUT INTRODUCER (UNK) | DYB | MEDTRONIC INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |