FDA Adverse Event
Injury
Summary report: N
PASSIVE PLUS DX
MDR report key: 2240243
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05444
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- September 20, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- P960030
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV
- 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 THE PATIENT WAS SEEN IN THE EMERGENCY ROOM WITH A HEART RATE OF 30 BPM. THE RIGHT VENTRICULAR LEAD IMPEDANCE WAS GREATER THAN OR EQUAL TO 2000 OHMS. THE LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PASSIVE PLUS DX | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1346T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention | (B)(4) |