FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2812490
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16448
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- September 26, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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, ANALYZED AND THE OUTER INSULATION WAS KINKED/BUCKLED. IT WAS NOTED THAT ALL OF THE CONDUCTORS WERE STRETCHED, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT AND THE LEAD WAS STRETCHED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT OF A RIGHT ATRIAL LEAD, THERE WAS A QUESTIONABLE OUTER INSULATION BREAK. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. 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 | 92 YR | Other |