FDA Adverse Event
Malfunction
Summary report: N
ADVISA DR MRI SURESCAN
MDR report key: 6005650
·
Received October 6, 2016
Report
- Report Number
- 9614453-2016-05936
- Event Type
- Malfunction
- Date Received
- October 6, 2016
- Date of Event
- July 25, 2016
- Report Date
- July 25, 2016
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
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 AFTER THE IMPLANT, IT WAS DIFFICULT TO KEEP THE PATIENT AT REST. THE PATIENT APPARENTLY TOUCHED THE PACEMAKER POCKET AND THE DEVICE MIGRATED CAUSING A DISLODGEMENT OF THE RIGHT VENTRICULAR LEAD. LEAD MEASUREMENTS OF THE RIGHT VENTRICULAR LEAD INDICATED LOW SENSING AND UNMEASURABLE PACING THRESHOLD. THE DEVICE MODE WAS REPROGRAMMED TO AAI AND THE PATIENT IS BEING MONITORED. THE DEVICE AND 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 |
|---|---|---|---|---|---|---|---|
| 655713 | ADVISA DR MRI SURESCAN | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | IPG MFG SWITZERLAND | A3DR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | 5076 LEAD |