FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 4163013
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12527
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- July 22, 2014
- Report Date
- August 7, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED AN ATRIAL LEAD PERFORATION WITH PERICARDIAL EFFUSION. THE PATIENT REQUIRED A PERICARDIAL TAP/DRAIN AND THE LEAD WAS REMOVED. IT WAS ALSO REPORTED THE PATIENT EXPERIENCED ATRIOVENTRICULAR (AV) BLOCK POST MYOCARDIAL INFARCTION. THE AV BLOCK RESOLVED AND THE PHYSICIAN ELECTED NOT TO REIMPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640218 | CAPSUREFIX NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00053 YR | Hospitalization| L| R | 5076-58 LEAD, A2DR01 IPG |