MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MULTIGEN RADIOFREQUENCY GENERATOR; DEVICE, ELECTROCONVULSIVE THERAPY

Model Number	0406900000
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Shock (2072); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced a shock during testing of the device.No medical intervention was necessary and no additional adverse consequences were reported.
Additional Manufacturer Narrative
Correction: b1 this correction is being filed to update the type of reportable event.
Event or Problem Description
It was reported that the patient experienced a shock during testing of the device.No medical intervention was necessary and no additional adverse consequences were reported.
Event or Problem Description
It was reported that the patient experienced a shock during testing of the device.No medical intervention was necessary and no additional adverse consequences were reported.
Additional Manufacturer Narrative
Corrected data: d9, product availability h3 other text : device not returned.

• Brand Name: MULTIGEN RADIOFREQUENCY GENERATOR
• Common Device Name: DEVICE, ELECTROCONVULSIVE THERAPY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9714991
• Report Number: 0001811755-2020-00465
• Device Sequence Number: 2928107
• Product Code: GXD
• UDI-Device Identifier: 07613154578443
• UDI-Public: 07613154578443
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0406900000
• Device Catalogue Number: 0406900000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 11/28/2020; 05/11/2021
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 12/01/2020; 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1