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

Model Number 97714

Device Problems Unintended Collision (1429); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 03/21/2017

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.The patient reported that the implant wasn't working for his sciatic nerve, particularly when having it on for 6-7 hours and walking.The patient reported having an adjustment with a manufacturer¿s representative (rep) in (b)(6) 2017.The patient reported that he had a fall, where he caught it more with his hand/arm.No further complications anticipated.

Event Description

Additional information was received from a consumer.It was reported that the steps taken to resolve the stimulation therapy not helping was that there were changes to stimulation made by a manufacturer's representative (rep).No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient on june 13, 2017.The patient reported that he was getting zapped when he turned his implantable neurostimulator (ins) on from mri mode.The patient clarified that this was not a complaint and was the normal feeling when stimulation was on.The patient said he wished it would cover his sciatic nerve more and farther up his back.The patient said he thinks things might be getting worse in his back or that something was wrong.The patient thinks his sciatica was becoming more of a problem than before.The patient had the device adjusted a month ago.The reprogramming was for his sciatic nerve issue.The patient said that after reprogramming it feels like someone is banging on his bone with a little hammer.The patient said it seems to work well enough but it wasn't enough and was wondering if he should increase stimulation.It was reviewed that the level of stimulation should be at a comfortable level.The patient said he is on group c and has adaptive stim is turned on but the amplitude does not change with his body positions.Upon troubleshooting, it was found the patient was not on an adaptive stim compatible group.The patient was instructed to cycle through his groups and group a was the only adaptive stim group and that he amplitude will only change with positions on an adaptive stim group.The patient mentioned he doesn't need the therapy when he is sleeping and only needs it when he is up and about and moving.The patient was redirected to their healthcare provider.No further complications were reported/anticipated.The indication for implant was spinal pain.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6518161
• MDR Text Key: 73613103
• Report Number: 3004209178-2017-08973
• 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,Followup,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2017
• Date Device Manufactured: 11/12/2015
• 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: 63 YR