FDA Adverse Event
Injury
Summary report: N
INTEGRITY ADX DR
MDR report key: 3925401
·
Received January 15, 2014
Report
- Report Number
- 2017865-2014-08847
- Event Type
- Injury
- Date Received
- January 15, 2014
- Date of Event
- September 27, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWP
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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. EVALUATION DESCRIPTION INCLUDED. ANALYSIS CONFIRMS NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC. THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38248 | INTEGRITY ADX DR | IMPLANTABLE PACEMAKER PULSE GENERATOR, LWP | LWP | ST. JUDE MEDICAL, INC., CRMD | 5360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |