FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2811300
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16107
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): OUTER INSULATION BREACHED, THE PROXIMAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM; FULL LEAD RETURNED AND ANALYZED.
Description of Event or Problem · 1
THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DETERMINED THAT THE LEAD WAS REPLACED DUE TO DISLODGEMENT. 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 | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization| R | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD |