FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX MRI SURESCAN
MDR report key: 3861664
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-07211
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- April 25, 2014
- Report Date
- April 25, 2014
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. VISUAL SUMMARY ANALYSIS INDICATED DAMAGED AT IMPLANT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE PHYSICIAN FELT THE RIGHT ATRIAL (RA) LEAD INSULATION HAD BEEN COMPROMISED WHILE CONNECTING THE LEAD TO THE PORT. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339751 | CAPSUREFIX MRI SURESCAN | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 5086MRI52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | A2DR01 IPG |