FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 1924340
·
Received December 14, 2010
Report
- Report Number
- 2649622-2010-13522
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- May 1, 2010
- 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
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE PATIENT TURNED AT THE WAIST TO THE RIGHT, NOISE WAS SEEN ON BOTH THE RIGHT ATRIAL LEAD AND THE RIGHT VENTRICULAR LEAD. THE RIGHT ATRIAL LEAD WAS REPORTED TO BE OVERSENSING THE NOISE AND THE RIGHT VENTRICULAR LEAD WAS NOT SENSING THE NOISE; HOWEVER, THE SHORT INTERVAL COUNTER WAS ELEVATED, INDICATING OVERSENSING. BOTH LEADS REMAIN IN USE. 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 | 69 YR | Other | (B)(4) IMPLANTABLE PULSE GENERATOR |