FDA Adverse Event
Malfunction
Summary report: N
PASSIVE PLUS DX LEAD
MDR report key: 688291
·
Received March 10, 2006
Report
- Report Number
- 2017865-2006-00413
- Event Type
- Malfunction
- Date Received
- March 10, 2006
- Date of Event
- January 1, 2006
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INFORMATION RECEIVED FROM THE FIELD NOTES THAT THE PATIENT HAD AN OLD PACEMAKER SYSTEM ON THE RIGHT SIDE AND A NEW SYSTEM WAS IMPLANTED ON THE LEFT IN DECEMBER 2005. THE OLD SYSTEM WAS PROGRAMMED TO OVO MODE AND LEFT IMPLANTED. THE PATIENT WAS IN THE HOSPITAL AND SEVERAL PAUSES >2 SECONDS WERE SEEN. THE NEWLY IMPLANTED DEVICE WAS PROGRAMMED TO DOO TO AVOID CONTINUED OVERSENSING. THE PATIENT WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PASSIVE PLUS DX LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1346T/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR |