FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS MRI
MDR report key: 2810630
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-15768
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- September 6, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED SYNCOPE AFTER THERE WAS LOSS OF CAPTURE ON THE ATRIAL AND VENTRICULAR PACING LEADS. THE PATIENT SUBSEQUENTLY FELL AND FRACTURED AN ANKLE. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE DEVICE AND LEADS WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS MRI | IMPLANTABLE PACING LEAD | NVN | MEDTRONIC PUERTO RICO, INC. | 5086MRI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| L| R |