FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2130933
·
Received June 16, 2011
Report
- Report Number
- 2649622-2011-10308
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- April 26, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Removal / Correction Number
- ASKU
- 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 FOR (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED AND IT WAS FOUND THAT THERE IS INTERMITTENCY BETWEEN THE PIN AND CAP ON THE CONNECTOR. THERE WAS BLOOD IN/ON THE HELIX MECHANISM.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE ATRIAL LEAD HAD HIGH IMPEDANCE. THE LEAD WAS REMOVED AND REPLACED WITH ANOTHER LEAD. 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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |