FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1072977
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03707
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- March 20, 2008
- 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; PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED. OUTER INSULATION BREACHED DEPRESSION. PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED. DEVICE CONCLUSION: CHANGED ON LEAD AS PARTIAL LEAD RETURNED IN SEGMENTS.
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 | Other| R | KDR701 IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD |