FDA Adverse Event
Malfunction
Summary report: N
IDENTITY ADX SR
MDR report key: 4143178
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-05665
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- May 29, 2012
- Manufacturer
- ST. JUDE MEDICAL, CRMD
- Product Code
- DXY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A FOLLOW UP THE DEVICE BATTERY DATA COULD NOT BE READ. REINTERROGATION HAD NO EFFECT. THERE WAS NO RESOLUTION TO THE ISSUE AND THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31915 | IDENTITY ADX SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, CRMD | 5180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR |