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

Model Number 97702

Device Problems Electromagnetic Interference (1194); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330); Insufficient Information (4580)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.The reason for call was pt said they were looking to make an appointment with their rep but lost the reps number.  pt said they had the ins turned up high and their back was still "killing" them.Pt said the pain had been since they had surgery back in november on thanksgiving day.The patient was redirected to their healthcare provider to further address the issue.Pt was escalated since pss could not give out rep info/did not have rep call records.Pss continued to redirect pt back to hcp as hcp had the rep contact the pt 2 to 3 weeks ago but pt had lost the reps contact information.Additional information received.Patient responded back from follow up sent.Patient reiterated they had surgery (b)(6) 2020 and indicated device had not been turned up.Patient reported when they were hurting they were sure it was from surgery.They didn't have their "meter" with them and no one could bring it.Patient reported when they got home, a week went by and they started chemo, also had a ct scan.Patient indicated they were asked by hcp if they had a device to which they responded they did but didn't have their "meter" with to turn device off.Patient reported hcp said it would be "no problem" and that it would only make the ekg feel funny but it really turned and raced high and then it backed off again without patient changing.When patient got home they could not get it to come back on.Patient's daughter suggested "meter" assuming controller needed new batteries so patient put in new batteries and was able to turn ins back on and turned down the stimulation.Patient reported they were unsure what number goes where and indicated after surgery they weren't sure after all the twisting, pulling that the paddles are in place.Patient reported where their battery component area is very sore and back and left leg hurts.Patient unsure if it's working properly and/or if it got moved out of place.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12590590
• MDR Text Key: 275186699
• Report Number: 3004209178-2021-14985
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169974883
• UDI-Public: 00643169974883
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/07/2021

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: 12/14/2020
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/07/2021
• Date Device Manufactured: 06/25/2019
• 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: 76 YR