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

Model Number 97714

Device Problems Display or Visual Feedback Problem (1184); Migration or Expulsion of Device (1395); Device Difficult to Program or Calibrate (1496)

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

Event Type  malfunction  

Event Description

It was originally reported that the patient was standing but the patient programmer showed that the patient was "lying l." when the patient was lying on right side, the implantable neurostimulator (ins) showed that she was lying left.On left side, it displayed lying on back; lying on back, it displayed lying on back; sitting, it displayed upright; standing, it displayed upright.It was noted that the patient was on group a and wanted to increase program 1.It was noted that the patient had been outside on the day of report and being colder increased the patient's problems so the increase would be just for now.It was noted that when the patient met with the manufacturer's representative "yesterday" to enable the adaptive stimulation feature, and the manufacturer's representative was having trouble getting the upright position.Additional information received four days later reported that last week the device reorientation was reset.It was noted that the proper position was confirmed with the patient programmer.It was noted that the next day, the patient made adjustments to his laying position but the next morning the orientation was incorrect again.It was noted that on the day of report, when the patient was upright, the device registered him as laying on his left side.It was noted that the ins in the pocket did not seem to be loose or moving around.It was noted that the patient was not a "twitter (twiddler)." there were no reported issues with recharging.The company representative reported on (b)(6) 2014 that an x-ray was performed and the battery moved ¼ of a turn to the left.The physician ordered an abdominal binder to give the battery stability while it heals down.It was confirmed on (b)(6) 2014 that the company representative saw the patient yesterday and his battery was stable.The adaptive stim was reprogrammed and then it was double checked.All was good when the patient left.

Manufacturer Narrative

Concomitant medical products: product id 97792, lot# n367052, implanted: (b)(6) 2014, product type: accessory; product id 97754, serial# (b)(4), product type: recharger; 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.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was later reported on (b)(6) 2014 that when the patient sits and leans back the implant site hurts.The patient wanted to know what could be done or if anything could be worn to relieve the pain.This occurred following implant.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 3695374
• MDR Text Key: 4300911
• Report Number: 3004209178-2014-04888
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2014
• Date Device Manufactured: 11/18/2013
• 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