FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 2952732
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00684
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- February 21, 2013
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P830061/S027
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY - THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 PRODUCTS: 4076 IMPLANTABLE PACING LEAD - 2008 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH/RISING THRESHOLDS. THE LEAD WAS CUT, 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 |
|---|---|---|---|---|---|---|---|
| 57304 | CAPSURE SP NOVUS | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 5086MRI45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00088 YR | Hospitalization| R | (B)(4) IMPLANTABLE PACEMAKER |