FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2813130
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16728
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 4, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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): THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE IMPLANT PROCEDURE, THERE WAS DIFFICULTY EXTENDING THE HELIX ON THE RIGHT VENTRICULAR LEAD. THE PHYSICIAN REPORTED NOT BEING ABLE TO EXTEND THE HELIX IN THE PATIENT'S BODY AND WHEN THE LEAD WAS REMOVED, THE PHYSICIAN HAD TO USE TWICE THE NORMAL AMOUNT OF ROTATIONS TO EXTEND THE HELIX. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other |