FDA Adverse Event
Malfunction
Summary report: N
VERIFY ENHANCED
MDR report key: 13657514
·
Received March 3, 2022
Report
- Report Number
- 3007566237-2022-00009
- Event Type
- Malfunction
- Date Received
- March 3, 2022
- Date of Event
- February 25, 2022
- Report Date
- March 2, 2022
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
V: PRODUCT ID 306001. PRODUCT TYPE: SCREENING DEVICE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 306001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 0
INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGENCY FREQUENCY. IT WAS REPORTED THAT PATIENT IS GETTING AN NLM COMMUNICATION ERROR. THEY ARE GOING TO CONTACT DOCTOR AND I LET HER KNOW WE WOULD TELL HER REPRESENTATIVE. SHE HAS NOT CHANGED TO THE OTHER SIDE AT THIS TIME. PATIENT INFORMED. THE PATIENT INFORMED THE LEADS HAD GOTTEN DISCONNECTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1336158 | VERIFY ENHANCED | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON | EZW | MEDTRONIC NEUROMODULATION | 353101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female |