FDA Adverse Event
Injury
Summary report: N
BROCKENBROUGH NEEDLE
MDR report key: 7864345
·
Received September 11, 2018
Report
- Report Number
- 9612164-2018-02355
- Event Type
- Injury
- Date Received
- September 11, 2018
- Date of Event
- September 5, 2018
- Report Date
- November 21, 2018
- Manufacturer
- MEDTRONIC MEXICO
- Product Code
- DRC
- UDI-DI
- 00613994663146
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 990061-055, LOT# C1-12989. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS CURRENTLY DOING WELL.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN RADIOFREQUENCY (RF) PROCEDURE, A PERICARDIAL EFFUSION WAS OBSERVED DURING THE TRANSEPTAL PUNCTURE. PERICARDIOCENTESIS WAS PERFORMED. THE CASE WAS ABORTED. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED, AND THE PATIENT WAS IN THE INTENSIVE CARE UNIT WITH RECOVERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 705833 | BROCKENBROUGH NEEDLE | TROCAR | DRC | MEDTRONIC MEXICO | EP003994S | 215406234 | 00613994663146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |