FDA Adverse Event
Injury
Summary report: N
PERVENOUS LEAD
MDR report key: 1050550
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01521
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 6, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- 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 POST PULSE GENERATOR REPLACEMENT, THE LEAD EXHIBITED LESS THAN 200 OHMS IMPEDANCE AND 2.5 V, 0.8 MS CAPTURE THRESHOLDS. THE POCKET WAS RE-OPENED, AND THE LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERVENOUS LEAD | NO BNCN FOUND FOR THIS DEVICE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 322-620 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |