MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION QUAD PLUS; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF), LEAD

Model Number N/A

Device Problems Break (1069); Device Inoperable (1663)

Patient Problems Pain (1994); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Discomfort (2330)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

Failure of spinal cord stimulator.Patient's coverage from his stimulation has not provided him with adequate pain relief.His local medtronic representative has tried multiple programming configurations with no improvement.He states that currently, only one electrode is operating properly which is providing him with relief in his right low back.He explains that if he turns the left low back lead on, it will cause a "burning sensation" in the surface of his skin overlying the lead.In regards to the two thoracic leads, he states that one lead is broken and nonfunctional, and the other one causes extreme discomfort down the anterior aspect of his right leg when it is turned on.

• Brand Name: QUAD PLUS
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF), LEAD
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave. ne; minneapolis MN 55421
• MDR Report Key: 4212544
• MDR Text Key: 18727537
• Report Number: 4212544
• 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
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 94