MAUDE Adverse Event Report: MEDTRONIC, INC. DBS¿; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number 3389S-40

Device Problem High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2018

Event Type  malfunction  

Event Description

When the electrode was placed in the patient's brain, the neurologist and neurosurgeon tested the impedance and it was "high", so the electrode was taken out and replaced.

• Brand Name: DBS¿
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): MEDTRONIC, INC.; 800 53rd ave., n.e.; minneapolis MN 55421
• MDR Report Key: 7453886
• MDR Text Key: 106276897
• Report Number: 7453886
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3389S-40
• Device Lot Number: VA1NSJ5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR