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

Model Number 97714

Device Problem Energy Output Problem (1431)

Patient Problems Device Overstimulation of Tissue (1991); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 09/27/2021

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 post lumbar laminectomy syndrome and spinal pain.It was reported that the patient stated last night, they charged their ins, but then their husband went to put batteries in the programmer and doesn't know if they touched a button they weren't supposed to, but the stimulation was all messed up now.The patient said they didn't sleep all night because nothing happened when patient tried to "charge my stimulator".The patient said the vibrations went in their left leg real lightly and then in their right leg didn't do anything.The patient then said today they went to try and "charge myself with the hand thing" and now the stimulation vibrations in patient's legs were too strong so they couldn't walk.  the patient connected with the programmer during the call and reported ins indicated it was on and half charged, and the intensity was "425".The patient said that level was what they had the stimulation set to before this issue started and the vibrations were not too strong then.The patient indicated the vibrations were still too strong during the call.Patient services (pss) asked if patient had tried to decrease stim yet, and patient said they tried decreasing earlier, but the number went up instead of down (later in the call patient discovered they were hitting the increase, not decrease button).The patient tried decreasing stimulation during the call, and patient said the numbers decreased, but even at "335" the vibration was still too strong.The patient then turned ins off using the ins off button.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue.Pss reviewed patient can continue to decrease ins further and see if that would help with the strong vibrations.

Event Description

Additional information was received.It was reported the patient had not used stim for a long period of time.Stim had come on at last amplitude setting causing overstimulation.The patient had an appointment on (b)(6) 2021 and were reprogrammed and re-educated.The issue was resolved.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• 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: 12569362
• MDR Text Key: 274536522
• Report Number: 3004209178-2021-14782
• Device Sequence Number: 1
• Product Code: LGW
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2021
• Date Device Manufactured: 02/18/2015
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 76 KG