FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS MRI
MDR report key: 2952504
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00604
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- November 2, 2012
- Report Date
- November 2, 2012
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO EVAL EXPLAINATION: DEVICE NOT RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN INFECTION WAS DISCOVERED DURING A ROUTINE DEVICE CHECK. THE PATIENT WAS HOSPITALIZED FOR IV ANTIBIOTIC ADMINISTRATION, BLOOD CULTURES, AND EXTRACTION OF THE SYSTEM. REPLACEMENT PRODUCT WAS IMPLANTED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57140 | CAPSUREFIX NOVUS MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 5086MRI52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00040 YR | Hospitalization| R | 5086MRI IMPLANTABLE PACING LEAD |