FDA Adverse Event
Injury
Summary report: N
CAPSUREFIXNOVUS
MDR report key: 3154350
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06560
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- April 12, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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. ADDR01 PACEMAKER 2008-(B)(6); 5568-53 IMPLANTABLE PACING LEAD 2008-03-03; (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 THERE WAS A LEAD FRACTURE, OVERSENSING LEADING TO A PAUSE AND AN INCREASE IN THRESHOLD. IT WAS NOTED THAT THE PATIENT WAS DEPENDENT. THE LEAD WAS EXPLANTED 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 |
|---|---|---|---|---|---|---|---|
| 254812 | CAPSUREFIXNOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00085 YR | Hospitalization| L| R |