FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1791838
·
Received August 10, 2010
Report
- Report Number
- 2649622-2010-06931
- Event Type
- Injury
- Date Received
- August 10, 2010
- Date of Event
- May 24, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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: (B)(4) DISTAL CONDUCTOR FRACTURED; FULL LEAD WAS RETURNED AND ANALYZED. IT WAS OBSERVED INNER INSULATION ABRASION (BREACHED) AND OUTER INSULATION BREACHED CUT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD HAD A HIGH IMPEDANCE AND HAD AN APPARANT FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEE REPORTED AS A RESULT OF THIS EVENT.
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 | 51 YR | Required Intervention | KDR901 IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |