FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3155924
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-07323
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 21, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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. PRODUCT: 4076 IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD SENSING ISSUES WHICH WAS DETERMINED TO NON-FUNCTIONAL UNDERSENSING. THE PARAMETERS WERE ADJUSTED ON THE DEVICE, SENSING IMPROVED, BUT THEN OVERSENSING OF T-WAVES WAS NOTED. THE PARAMETERS WERE READJUSTED TO IMPROVE THE OVERSENSING AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 257635 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | Required Intervention | ADDRL1 IMPLANTABLE PULSE GENERATOR |