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

Model Number 3389

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2017

Event Type  malfunction  

Event Description

The dbs lead was passed to sterile field.The lead was noted to be bent.The lead never reached the patient.

• Brand Name: DBS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave. ne; minneapolis MN 55432
• MDR Report Key: 6947601
• MDR Text Key: 89284977
• Report Number: 6947601
• Device Sequence Number: 1
• Product Code: MHY
• 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: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Expiration Date: 05/16/2020
• Device Model Number: 3389
• Device Catalogue Number: 33895-40
• Device Lot Number: VA17542
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES