FDA Adverse Event
Malfunction
Summary report: N
IDENTITY ADX XL DR
MDR report key: 2240267
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05898
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- April 26, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWP
- PMA / PMN Number
- P880086
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE AT A ROUTINE VISIT THE PATIENT EXPERIENCED A -JOLT- AND VIOLENT SPASM WHEN THE NURSE WAS TAKING THE PT'S BLOOD PRESSURE. IT IS BELIEVED THAT THERE MAY BE A MALFUNCTION WITH THE PULSE GENERATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY ADX XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5386 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |