FDA Adverse Event
Malfunction
Summary report: N
INSPIRE
MDR report key: 7936255
·
Received October 4, 2018
Report
- Report Number
- 3007666314-2018-00040
- Event Type
- Malfunction
- Date Received
- October 4, 2018
- Date of Event
- October 2, 2018
- Report Date
- October 4, 2018
- Manufacturer
- INSPIRE MEDICAL SYSTEMS INC.
- Product Code
- MNQ
- UDI-DI
- 00855728005192
- PMA / PMN Number
- P130008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PATIENT FELT THAT HIS IPG MAY HAVE SHIFTED POSITION AND THE SENSE LEAD WAS PROVIDING ABNORMAL WAVEFORMS AND IMPEDANCE READINGS. REVISION SURGERY WAS CONDUCTED TO REPLACE THE SENSE LEAD AND ADDRESS DEVICE MIGRATION.
Description of Event or Problem · 1
FOLLOW UP REPORT TO MDR 3007666314-2018-00040: PATIENT UNDERWENT REVISION SURGERY. ORIGINAL SENSE LEAD APPEARED TO BE DAMAGED, I.E. CUTS IN THE OUTER TUBING. IT WAS REPLACED DURING THE REVISION SURGERY. NO FURTHER ISSUES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 774119 | INSPIRE | SENSING LEAD | MNQ | INSPIRE MEDICAL SYSTEMS INC. | MODEL 4323 | 00855728005192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |