FDA Adverse Event
Malfunction
Summary report: N
SELECTSECURE MRI SURESCAN
MDR report key: 12679453
·
Received October 22, 2021
Report
- Report Number
- 3008973940-2021-03840
- Event Type
- Malfunction
- Date Received
- October 22, 2021
- Date of Event
- September 30, 2021
- Report Date
- October 22, 2021
- Manufacturer
- MEDTRONIC SINGAPORE OPERATIONS
- Product Code
- NVN
- UDI-DI
- 00763000130800
- PMA / PMN Number
- P030036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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 THE LEFT BUNDLE BRANCH LEAD EXHIBITED TWAVE OVER-SENSING. THE 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 |
|---|---|---|---|---|---|---|---|
| 1583485 | SELECTSECURE MRI SURESCAN | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) | NVN | MEDTRONIC SINGAPORE OPERATIONS | 383069 | 00763000130800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | 5076-58 LEAD, W3DR01 IPG |