FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2955506
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-01432
- Event Type
- Injury
- Date Received
- February 11, 2013
- Report Date
- December 4, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD PRE-SYNCOPE AND TACHYCARDIA SYMPTOMS. THE RIGHT VENTRICULAR (RV) LEAD HAD A POLARITY SWITCH WITH OVERSENSING OF T-WAVES AND NOISE. ALSO, THERE WERE PACING PAUSES DUE TO THE OVERSENSING. A CHEST X-RAY SHOWED THE LEAD HAD NOT MOVED, BUT HAD VERY LITTLE SLACK. THE MODE WAS REPROGRAMMED TO DOOR AND THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59384 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00034 YR | Required Intervention | (B)(4) IMPLANTABLE PULSE GENERATOR |