FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 3864630
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-07423
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- January 24, 2014
- Report Date
- April 3, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE DISTAL PORTION WAS RECEIVED MEASURING 45 CM. THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 5594 LEAD, IMPLANTED: (B)(6) 2009. (B)(4).
Description of Event or Problem · 1
THE RIGHT VENTRICULAR (RV) LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341284 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5092-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR | Hospitalization| R | P1501DR IPG |