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

Model Number 97712

Device Problems Device Operates Differently Than Expected (2913); Environmental Compatibility Problem (2929)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Dizziness (2194); Complaint, Ill-Defined (2331)

Event Date 07/30/2016

Event Type  malfunction  

Event Description

A patient reported that on (b)(6) 2016 they were at 10,000 feet and they felt stimulation three times stronger than they normally feel it.They felt their eyeballs, cheeks, and tongue vibrate.When they went back down in elevation, the sensation went away.Altitude compatibility was reviewed with the patient and it was recommended they follow up with their healthcare provider (hcp).The patient noted they have lead wires implanted in their head for "permanent brain freeze" symptom.On (b)(6) 2016 the patient reported that they got up to 14,000 feet in the mountains.They were told it could have been that their body oxygen level changed.When they climbed up their head did hurt a lot worse because it was at the point where electronics did not kill the pain any longer.The patient mentioned permanent brain freeze again and said they get flare ups and it has been like that even before the implant.It used to be so bad they would pass out.With the device, they do not pass out and the ins is doing a good job.Sometimes they still get dizzy.The flares ups were getting worse since the year prior to the report.The implantable neurostimulator (ins) was indicated for non-malignant 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, TOTALLY IMPLANTED FOR 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: 5905695
• MDR Text Key: 53098620
• Report Number: 3004209178-2016-17667
• Device Sequence Number: 1
• Product Code: LGW
• 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: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2015
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2016
• Date Device Manufactured: 09/24/2014
• 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: 65 YR