FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2790912
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14473
- Event Type
- Injury
- Date Received
- October 15, 2012
- Date of Event
- July 23, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN/ON THE HELIX MECHANISM.
Description of Event or Problem · 1
IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST IMPLANT, THE PATIENT THE PATIENT HAD A SYNCOPAL SPELL AND WAS TAKEN TO THE EMERGENCY DEPARTMENT WITH EXTERNAL PACING REQUIRED. THE THRESHOLD HAD INCREASED, OVERSENSING WAS NOTED, AND NON CAPTURE WAS NOTED. THE OVERSENSING WAS REPRODUCED BY MANEUVERS. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER 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. | 4076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization| L| R | 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR |