MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION DBS LEAD; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Lot Number VAOWJGZ

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/22/2015

Event Type  malfunction  

Event Description

Lead (1) is bad, and it failed.Only the lead is bad.

• Brand Name: DBS LEAD
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd avenue, n.e.; minneapolis, MN 55421
• MDR Report Key: 4951780
• MDR Text Key: 6196229
• Report Number: 4951780
• Device Sequence Number: 1
• Product Code: MHY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Lot Number: VAOWJGZ
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR