FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 2955414
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-01418
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- December 13, 2012
- Report Date
- December 13, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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. CONCOMITANT CONTINUED: 4092-52 IMPLANTABLE PACING LEAD (B)(6) 2005. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT ATRIAL LEAD HAD INTERMITTENT LOSS OF CAPTURE. THRESHOLD HAS BEEN CHRONICALLY HIGH. AFTER TESTING, THE LEAD WAS REPROGRAMMED AND REMAINS IN USE FOR FURTHER EVALUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58900 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4592-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00094 YR | Required Intervention | ADDRS1 IMPLANTABLE PULSE GENERATOR |