FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 3152173
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-05529
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- March 1, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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: 5076 IMPLANTABLE PACING LEAD (B)(6) 2003; ADDR01 IMPLANTABLE PULSE GENERATOR (B)(6) 2011 ; (B)(4), IMPLANTABLE TISSUE VALVE, IMPLANTED (B)(6) 2003. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD NOISE AND NO CAPTURE AT 3 VOLTS. THE RA LEAD WAS CAPPED AND REPLACED. DURING THE REVISION, WHILE THE DEVICE WAS OUT OF THE POCKET, POCKET STIMULATION WAS NOTED. THE POCKET STIMULATION COULD BE AN INDICATION OF POSSIBLE INSULATION DAMAGE, SO THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252920 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |