FDA Adverse Event
Injury
Summary report: N
UNKNOWN INTERSTIM NEUROSTIMULATOR
MDR report key: 4240889
·
Received November 10, 2014
Report
- Report Number
- 3007566237-2014-03279
- Event Type
- Injury
- Date Received
- November 10, 2014
- Report Date
- February 19, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).
Additional Manufacturer Narrative · 1
REVIEW OF THIS MDR SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT ¿NEEDED¿ AN APPOINTMENT AND TO GIVE URINE. THE HEALTHCARE PROVIDER (HCP) STATED THE PATIENT WAS ¿LIKELY TO HAVE LEAD REPLACED.¿ PATIENT OUTCOME, SYMPTOMS, AND PRODUCT ISSUES WERE NOT KNOWN. FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 721884 | UNKNOWN INTERSTIM NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |