FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS MRI
MDR report key: 2790291
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14401
- Event Type
- Injury
- Date Received
- October 15, 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
- 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. EVALUATION SUMMARY : (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON THE PROXIMAL CONDUCTOR AND BLOOD IN/ON THE HELIX MECHANISM. THE OUTER INSULATION HAD A BREACHED CUT AND THERE WAS APPARENT EXPLANT DAMAGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD HAD A POTENTIAL PERFORMANCE ISSUE; THE LEAD MOVED. DURING THE REPOSITIONING PROCEDURE, THE HELIX WOULD NOT EXTEND. THE LEAD WAS EXPLANTED AND WAS REPLACED. 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R | 6947M IMPLANTABLE TACHY LEAD| 4296 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |