FDA Adverse Event
Injury
Summary report: N
TVL ADX
MDR report key: 1050725
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01682
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 14, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN
Additional Manufacturer Narrative · 1
ANALYSIS CONFIRMED THE REPORTED NOISE. THE INNER INSULATION HAD A THROUGH ABRASION BETWEEN THE PACING COILS. THE DAMAGE WAS LOCATED UNDER THE SHOCK COIL, AT 3.3-3.7CM FROM THE TIP. THE DAMAGE IS CONSISTENT WITH THE REPORTED NOISE AND INAPPROPRIATE SHOCKS OCCURING WHEN THE COILS MADE CONTACT WITH EACH OTHER.
Description of Event or Problem · 1
THE LEAD WAS EXPLANTED WHEN MULTIPLE INAPPROPRIATE THERAPIES WERE DELIVERED DUE TO A SUSPECTED FRACTURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DECEASED. IT WAS NOTED THAT THE LEAD EXHIBITED A MECHANICAL PROBLEM. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TVL ADX | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1559/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |