FDA Adverse Event
Malfunction
Summary report: N
SELECTSECURE MRI SURESCAN
MDR report key: 14447745
·
Received May 20, 2022
Report
- Report Number
- 2649622-2022-09638
- Event Type
- Malfunction
- Date Received
- May 20, 2022
- Date of Event
- April 22, 2022
- Report Date
- May 19, 2022
- Manufacturer
- MPRI
- Product Code
- NVN
- UDI-DI
- 00763000130800
- PMA / PMN Number
- P030036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) - LEFT BUNDLE BRANCH (LLB) LEAD EXHIBITED INTERMITTENT OVERSENSING ON STORED ELECTROGRAMS (EGM). THE RV - LLB LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2469961 | SELECTSECURE MRI SURESCAN | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) | NVN | MPRI | 383069 | 00763000130800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Female | 457445 LEAD, W1DR01 IPG |