FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2812622
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-17444
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- September 27, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVALUATION SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE DISTAL LOW VOLTAGE ELECTRODE HAD BLOOD AND THE DISTAL END APPEARED TO HAVE DAMAGE. ALSO THE LEAD APPEARED TO BE STRETCHED AND DAMAGED AT IMPLANT.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD HAD A CONSISTENTLY HIGH IMPEDANCE READING OF APPROXIMATELY 1500 TO 1700 OHMS AND POOR SENSING AT APPROXIMATELY 5 MILLIVOLTS. THE RV LEAD WAS REMOVED AND REPLACED. 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 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MEDTRONIC PUERTO RICO, INC. | 5076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other |