FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1072704
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03795
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- October 23, 2007
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY - NO ANOMALIES FOUND. FULL LEAD RETURNED AND ANALYZED.
Description of Event or Problem · 1
ASKU
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5076 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 5076 IMPLANTABLE PACING LEAD| AT501 IMPLANTABLE PULSE GENERATOR |