FDA Adverse Event
Injury
Summary report: N
IDENTITY ADX SR
MDR report key: 3925746
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15231
- Event Type
- Injury
- Date Received
- July 10, 2014
- Date of Event
- May 28, 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS FOUND NORMAL BATTERY DEPLETION. THE REPORTED INABILITY TO READ DATA WAS A RESULT OF A SOFTWARE ISSUE.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT WAS PRESENTED IN CLINIC FOR A ROUTINE FOLLOW-UP AND UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED A DIAGNOSTICS ANOMALY. THE DEVICE WAS EXPLANTED DUE TO A NORMAL ELECTIVE REPLACEMENT INDICATOR ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 404453 | IDENTITY ADX SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5180 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |