FDA Adverse Event
Injury
Summary report: N
INDENTITY DR
MDR report key: 396620
·
Received May 10, 2002
Report
- Report Number
- 2017865-2002-00461
- Event Type
- Injury
- Date Received
- May 10, 2002
- Date of Event
- March 8, 2002
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INFORMATION RECEIVED DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES THAT DURING THE IMPLANT PROCEDURE, AFTER THE POCKET WAS CLOSED, MEASURED DATA FOR THE ATRIAL LEAD WAS 0UJ PULSE ENERGY, 0UC PULSE CHARGE, AND >2500 OHMS LEAD IMPEDANCE. AN X-RAY SHOWED THAT THE ATRIAL LEAD DID NOT APPEAR TO BE FULLY CONNECTED TO THE PULSE GENERATOR. THE POCKET WAS OPENED AND THE LEAD WAS REINSERTED INTO THE GENERATOR, AFTER WHICH NORMAL FUNCTION ENSUED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDENTITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5370 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |