FDA Adverse Event
Injury
Summary report: N
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
MDR report key: 6520685
·
Received April 25, 2017
Report
- Report Number
- 3007566237-2017-01580
- Event Type
- Injury
- Date Received
- April 25, 2017
- Report Date
- April 25, 2017
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED FROM A CONSUMER (CON) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT WAS TAKING AZO AND CIPRO ALL THE TIME AND DIDN¿T HAVE BLADDER INFECTIONS. THERE WERE NO DEVICE ISSUES OR FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301529 | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_INTERSTIM_INS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |