FDA Adverse Event
Injury
Summary report: N
MICRONY II SR+
MDR report key: 3926305
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15596
- Event Type
- Injury
- Date Received
- July 10, 2014
- Date of Event
- April 9, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWP
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LABELING ON THE BOX CONTAINING THE PULSE GENERATOR DID NOT GIVE CLEAR INFORMATION ABOUT THE LEADS THAT WERE COMPATIBLE WITH IT. THE DEVICE WAS MISTAKENLY IMPLANTED WITH A UNIPOLAR EPICARDIAL LEAD. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405013 | MICRONY II SR+ | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 2525T | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |