MAUDE Adverse Event Report: MEDTRON IC NEUROMODULATION MEDTRONIC 2X4 POCKET ADAPTOR; DEEP BRAIN STIMULATOR POCKET ADAPTER

Model Number 64002

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/25/2016

Event Type  Injury  

Event Description

On (b)(6) 2016 pt had surgery to replace depleted dbs generator.On (b)(6) 2016 pt's essential tremors poorly controlled.On (b)(6) 2016 pt taken back to surgery to determine cause.Surgeon identifies pocket adapter as source of high impedance.Pocket adapter replaced.Old pocket adapter returned to manufacturer.

• Brand Name: MEDTRONIC 2X4 POCKET ADAPTOR
• Type of Device: DEEP BRAIN STIMULATOR POCKET ADAPTER
• Manufacturer (Section D): MEDTRON IC NEUROMODULATION; minneapolis MN
• MDR Report Key: 5906812
• MDR Text Key: 53334232
• Report Number: 5906812
• Device Sequence Number: 1
• Product Code: PJS
• 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: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 64002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2016
• Distributor Facility Aware Date: 02/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 63