MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION VECTRIS SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 977A260

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Event Description

The patient had a spinal nerve stimulator placed in (b)(6) 2017.One of the two leads detached from the device (b)(6) 2017 and the patient came to or for retrieval of lead.The date that the lead detached is unknown.

• Brand Name: VECTRIS SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave. n.e.; minneapolis MN 55421
• MDR Report Key: 6875310
• MDR Text Key: 86588988
• Report Number: 6875310
• Device Sequence Number: 1
• Product Code: LGW
• 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: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 977A260
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2017
• Event Location: Home
• Date Report to Manufacturer: 09/06/2017
• Type of Device Usage: N
• Patient Sequence Number: 1