PERIPHERAL NERVE STIMULATOR STQ4-RCV-A0

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-22 for PERIPHERAL NERVE STIMULATOR STQ4-RCV-A0 manufactured by Stimwave Technologies Inc..

MAUDE Entry Details

• Report Number: 3010676138-2020-00003
• MDR Report Key: 9618198
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2020-01-22
• Date of Report: 2020-01-22
• Date of Event: 2019-12-26
• Date Mfgr Received: 2019-12-27
• Device Manufacturer Date: 2018-09-05
• Date Added to Maude: 2020-01-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS MARY ANN GREENAWALT
• Manufacturer Street: 1310 PARK CENTRAL BOULEVARD S.
• Manufacturer City: POMPANO BEACH FL 33064
• Manufacturer Country: US
• Manufacturer Postal: 33064
• Manufacturer Phone: 8009655134
• Manufacturer G1: STIMWAVE TECHNOLOGIES INC.
• Manufacturer Street: 1310 PARK CENTRAL BOULEVARD S.
• Manufacturer City: POMPANO BEACH FL 33064
• Manufacturer Country: US
• Manufacturer Postal Code: 33064
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PERIPHERAL NERVE STIMULATOR
• Generic Name: PERIPHERAL NERVE STIMULATOR, PRODUCT CODE: GZF
• Product Code: GZF
• Date Received: 2020-01-22
• Model Number: STQ4-RCV-A0
• Lot Number: SWO190423
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STIMWAVE TECHNOLOGIES INC.
• Manufacturer Address: 1310 PARK CENTRAL BOULEVARD S. POMPANO BEACH FL 33064 US 33064

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-01-22