FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX NOVUS MRI SURESCAN
MDR report key: 8825805
·
Received July 25, 2019
Report
- Report Number
- 2649622-2019-13045
- Event Type
- Malfunction
- Date Received
- July 25, 2019
- Date of Event
- July 2, 2019
- Report Date
- August 13, 2019
- Manufacturer
- MPRI
- Product Code
- DTB
- UDI-DI
- 00643169708204
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE HELIX WAS ABLE TO EXTEND AND RETRACT WITHIN SPECIFICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 THAT DURING THE IMPLANT PROCEDURE, THE HELIX WOULD NOT EXTEND WHEN USING THE ROTATION TOOL. THE LEAD WAS ATTEMPTED NOT USED 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 |
|---|---|---|---|---|---|---|---|
| 622064 | CAPSUREFIX NOVUS MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 407658 | 00643169708204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |