FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX MRI SURESCAN
MDR report key: 4162590
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12697
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- July 21, 2014
- Report Date
- July 21, 2014
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING AND APPARENT EXPLANT DAMAGE. CONCOMITANT PRODUCT: RVDR01 IPG, IMPLANTED: (B)(6) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD BECAME DISLODGED. THE LEAD WAS REMOVED 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 |
|---|---|---|---|---|---|---|---|
| 643708 | CAPSUREFIX MRI SURESCAN | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 5086MRI45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR | Hospitalization| R | 5086MRI52 LEAD |