FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS MRI
MDR report key: 2201653
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-11159
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 13, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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 THAT THE INNER SEAL OF THE LEAD PACKAGING WAS COMPROMISED (PARTIALLY OPENED); THE PACKAGING DID NOT LOOK RIGHT AND LOOKED DEFECTIVE. THEREFORE THE LEAD WAS NOT REMOVED FROM THE PACKAGING OR INTO THE STERILE FIELD. A DIFFERENT LEAD WAS USED TO COMPLETE THE IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN 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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |