MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problems Display or Visual Feedback Problem (1184); Energy Output To Patient Tissue Incorrect (1209); Device Operates Differently Than Expected (2913)

Patient Problems Irritation (1941); Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099)

Event Date 05/19/2016

Event Type  malfunction  

Event Description

A manufacturer representative reported on (b)(6) 2016 that a consumer stated stimulation was remaining on even after stimulation had been turned off.The representative turned stimulation to 0 and off, and the consumer still felt residuals.The first occurrence of this was three (3) days post-surgery for a few hours, and the other/second occurrence was still in progress for several days.It was noted that the consumer turned stimulation off on (b)(6) 2016 and had been feeling stimulation for the past three days.Information received from the representative on (b)(6) 2016 reported he would be seeing the consumer, as she continued to feel stimulation, but positional.She felt stronger stimulation when she laid down and felt the appropriate stimulation coverage, but it was irritating.The representative confirmed stimulation was off with the clinician and patient programmers.The consumer's doctor ordered an mri, as the consumer continued to feel stimulation and the stimulator was off.Troubleshooting reviewed device data and noted the last clinician programmer session was (b)(6) 2016 and noted five (5) recharge sessions captured between (b)(6).Three were short between 2-6 minutes long, and the other two were 41 and 57 minutes long.Since (b)(6) 2016, the consumer had stimulation off briefly on (b)(6), but stimulation was turned back on shortly thereafter (in less than 1 minute).No impedances were done.Since the consumer had not been implanted for that long, it was reviewed to consider that positioning of the leads was creating a sense of stimulation.Indication for use included spinal pain.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the manufacturing representative reported that cause of the stimulation was not determined.The patient has not been feeling stimulation "as of late".

Manufacturer Narrative

Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5729168
• MDR Text Key: 47520276
• Report Number: 3004209178-2016-12318
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2016
• Date Device Manufactured: 03/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR