FDA Adverse Event
Injury
Summary report: N
CAPSURE Z NOVUS
MDR report key: 3993917
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09048
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 19, 2014
- Report Date
- May 19, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. CONCOMITANT MEDICAL PRODUCTS: 5054-58 LEAD, (B)(6) 2013. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT P-WAVE SENSING HAD DIMINISHED AND THAT CAPTURE THRESHOLDS HAD RISEN FOR THE RIGHT ATRIAL (RA) LEAD SINCE IMPLANT. LEAD DISLODGEMENT WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED WITH AN ACTIVE FIXATION LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471432 | CAPSURE Z NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5554-53 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00089 YR | Hospitalization| R | ADDRL1 DEVICE |