FDA Adverse Event
Injury
Summary report: N
CADENCE DEFIBRILLATION LEAD
MDR report key: 218073
·
Received April 9, 1999
Report
- Report Number
- 2938836-1999-00073
- Event Type
- Injury
- Date Received
- April 9, 1999
- Date of Event
- March 1, 1999
- Report Date
- March 1, 1999
- Manufacturer
- ST.JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIV.
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE LEAD WAS EXPLANTED DUE TO A FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CADENCE DEFIBRILLATION LEAD Implant | DEFIBRILLATION LEAD | LWS | ST.JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIV. | DP-5038 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other | DP-5038, ML-150, ML-150, V-145B, THERAPY DATE: NA. |