FDA Adverse Event
Malfunction
Summary report: N
VERITY ADX SR
MDR report key: 4150994
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-06612
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- September 25, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWP
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. 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 A DEVICE WAS UNABLE TO BE INTERROGATED. THE DEVICE WAS UNABLE TO BE INTERROGATED. THE DEVICE WAS ABLE TO BE INTERROGATED SUCCESSFULLY AT A LATER CHECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32052 | VERITY ADX SR | IMPLANTABLE PACEMAKER PULSE GENERATOR, LWP | LWP | ST. JUDE MEDICAL, INC., CRMD | 5156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR |