FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SP NOVUS
MDR report key: 3153646
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06142
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- March 7, 2013
- Report Date
- March 7, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, 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. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES.
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE IMPLANT PROCEDURE, EVERYWHERE THE PHYSICIAN PLACED THE LEAD IN THE RIGHT VENTRICLE IT REGISTERED HIGH IMPEDANCE MEASUREMENTS OF OVER 2000 OHMS. THE LEAD WAS REMOVED AFTER 45 MINUTES AND A NEW LEAD WAS PLACED THAT REGISTERED GOOD MEASUREMENTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255957 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4092-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00090 YR |