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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

Notes from the operative report: this patient "has a dorsal column stimulator placed multiple years ago for post-laminectomy syndrome and chronic radiculopathy, it gives pt complete relief of pain.The generator was at end of life and was replaced ((b)(4) 2014).The new generator has caused in a shocking sensation into the buttocks area; it is bothersome when pt turns it on and it is relieved when pt turns it off.Presumably, there is some sort of a voltage leak.Patient is here to have this generator replaced with a new one.I also replaced the extension cable."."incision was made over the pulse generator.This was dissected free from the surrounding tissues and set aside.Second incision was made over the extension cable connection.This was disconnected from the stimulator and also sent with the generator for evaluation by the medtronics corporation.A third incision was made over the left iliac crest.This was a subcutaneous pocket large enough to accommodate pulse generator that was created.A new extension cable was attached to the stimulator.The insulation was placed over the connection and secured with 0 silk.Subcutaneous tunnel was created and wires were passed through the tunnel.The wires were then secured to the new pulse generator.Pulse generator was secured with a new subcutaneous pocket." there were no complications.

• Brand Name: PRIMEADVANCED SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central avenue n.e; rcw 225; minneapolis, MN 55432
• MDR Report Key: 4738983
• MDR Text Key: 5768775
• Report Number: 4738983
• Device Sequence Number: 1
• Product Code: GZB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/27/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2015
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2015
• Patient Sequence Number: 1