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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2015

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are : product id 977a160, serial # (b)(4), implanted: (b)(6) 2015, product type lead; product id 977a160, serial # (b)(4), implanted: (b)(6) 2015, product type lead.(b)(4).

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.The patient reported that she just had a reprogramming session with a manufacturer¿s representative (rep) to see if she could get more pain relief.The patient reported that she had complex regional pain syndrome (crps) so it kind of kept spreading.The patient reported that the pain changed and moved around and reported it was like over time the device lost its effectiveness (for helping with the pain she had) and so she would get reprogrammed ¿quarterly¿ and went in about 4 times a year or every 3 months or so to get the programming updated.The patient reported that when they put in the ins they told her she had a lot of space in her spinal cord so it kept needing to be reprogramming because it moved around.The patient confirmed by it she meant lead.The patient reported that she was going to be working with her new managing physician for a while because he was going to be the one to implant a second stimulator underneath her current ins.The patient reported that the second device was not for pain relief but rather it was supposed to prevent nerve da mage from spreading.The patient reported that she had the nerve damage and crps prior to getting the ins.No further complications anticipated.

Manufacturer Narrative

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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6418988
• MDR Text Key: 70409742
• Report Number: 3004209178-2017-05957
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2017
• Date Device Manufactured: 04/16/2015
• 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: 23 YR