FDA Adverse Event
Injury
Summary report: N
OPTISENSE
MDR report key: 1223931
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03380
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 12, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMAP960013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED NOISE RIGHT AFTER IMPLANT. THE NOISE ONLY OCCURRED WHEN TRYING TO PACE, AND WAS NOT REPRODUCIBLE WITH ISOMETRICS. THE PHYSICIAN ELECTED TO REPLACED THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTISENSE | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1699TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |