FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3993961
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09040
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 19, 2014
- Report Date
- May 19, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- 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. CONCOMITANT MEDICAL PRODUCTS: 5568-45 LEAD, IMPLANTED (B)(6) 1998. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS ADDITIONALLY REPORTED THAT THE RV LEAD HAD A POSSIBLE FRACTURE. THE LEAD WAS CAPPED AND WAS REPLACED WITH A NEW LEAD.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN INTERROGATION SHOWED THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD WARNING FOR HIGH IMPEDANCE, NOISE, AND VARYING SENSING. THE LEAD REMAINS IN USE FOR ADDITIONAL EVALUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470481 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00078 YR | Hospitalization| R | VEDR01 IPG |