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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); No Device Output (1435); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001)

Patient Problems Fall (1848); Electric Shock (2554)

Event Date 07/01/2021

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 failed back surgery syndrome and spinal pain.The reason for call was pt said they need a manufacturing representative (rep) for reprogramming and the pt had experienced "little shocks" from the spinal cord stimulator (scs) since (b)(6)2021.Pt fell two times as a result of the "little shocks." the patient was redirected to their healthcare provider to further address the issue.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain.The reason for call was pt stated they hadn't see a rep since covid started and asked how to meet with a rep to check on their ins/settings.Pt then said they will be able to charge the ins full, but would have trouble connecting afterwards.Pt said they would have to play with the equipment a couple times to get connected to the ins when trying to turn stim on.Pt also said they would be sitting and if they moved a different way, the stim would shut completely off.Pt also said they would be walking and stim would shut itself off and then turn back on all while pt was walking.When asked event date, pt said a month or so ago, during the holidays.Agent did not ask about the circumstances that led to the reported issue.The patient was redirected to their healthcare provider to further address the issue.The patient reported that they are no longer able to charge the implantable neurostimulator and are getting nervous.The patient cannot charge or turn on their implant.The patient noted that they were trying to find a manufacturer representative since their health care professional would not see them until a manufacturer representative serviced their implant.The patient was redirected to their health care professional.

Manufacturer Narrative

H3.Additional information regarding manufacturer report # 3004209178-2022-01711 will be submitted as a supplemental to this report.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: 12450296
• MDR Text Key: 270786353
• Report Number: 3004209178-2021-13604
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2022
• Date Device Manufactured: 06/13/2017
• 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: 58 YR
• Patient Sex: Female