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

Model Number 97702

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991)

Event Type  malfunction  

Event Description

Additional information was received on (b)(4) 2014 indicating that the stimulation was in the wrong location.The patient was complaining that whenever they turned it on she felt it in her legs and not her back which is where the pain was.This had been happening since they day it was put in so they we to see a technician and they tried to program it for an hour and they said it was ok to feel it a little on the legs, this was about two months ago.The patient has not had it on for over a month now but the day of the report they were having sever pain so they turned it on but she felt it in her legs.They tried the left and right side but did not know how to just get it in the back and not her legs, the patient did not want it in her legs at all just her back.It was noted that after surgery it took an hour to program it and it was noted that they should meet with their manufacturer representative once more.If additional information is received, a follow-up report will be sent.

Event Description

It was reported that the patient had an overstimulation sensation.The patient was able to successfully turn the stimulation off, but had received minimal or ineffective training on how to use the patient programmer (pp).The patient had the implantable neurostimulator (ins) implanted on (b)(6), but had been told by a healthcare provider (hcp) to go ahead and use the ins.On the pp, the patient saw a screen that said ¿zero, with some pictures on the top.¿ after turning the stimulation on, the patient could feel the stimulation in the back and legs, but did not need the stimulation in the legs.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 97740, serial# (b)(4), product type: programmer, patient.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Follow up information received reported that the patient still had concerns with their device therapy but was working with their doctor and/or manufacturer's representative.It was noted that no appointments were scheduled at the time of report.Should additional information be received a supplemental report will be filed.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4271007
• MDR Text Key: 5287907
• Report Number: 3004209178-2014-22078
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2014
• Initial Date FDA Received: 11/21/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/01/2014; 12/30/2014
• Date Device Manufactured: 01/18/2014
• 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: 00092 YR