FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 2954582
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-02354
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- December 4, 2012
- Report Date
- December 4, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. NO ANOMALIES WERE FOUND DURING ANALYSIS.
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 THE PATIENT IS DIAGNOSED WITH (B)(6) ENDOCARDITIS AND (B)(6). THE DEVICE AND LEAD WERE EXPLANTED WITH NO INTENTION OF REPLACEMENT AT THIS TIME. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57939 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5092-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR (IPG) |