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

Model Number 97714

Device Problems Energy Output Problem (1431); Battery Problem (2885); Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 12/19/2021

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that  last night, the patient went to turn their stimulation off and it went way, way high shocking.It took a while for the patient to turn off the stimulation for the patient was getting an error on the screen showing there was a problem communicating.The patient did not know what could have been pushed for the stimulation to go so high for it was bad.When patient went to turn off stimulation, the patient could not imagine they hit any button to increase the intensity like that.Usually the patient had the stimulation set to 4 but due to the patient's pain they probably imagined it was set to 20 intensity.

Manufacturer Narrative

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

Event Description

Additional information received from the manufacturing representative (rep) indicated that patient was able to recommunicate with device after new batteries were put in patient programmer.Then looked online to see how to turn device off to resolve the shocking.Patient would like to consult with implanting physician for possible replacement as they are not feeling comfortable with having it on.They weighed 160lbs at the time of the event.The rep called patient services (ps) and ps reviewed based on the note in this case, it sounds like this may have been an 'overstimulation' situation due to an ins off commandwhile a por was active.However, the caller is stating the pt told him something else.The caller states the pt said he was climbing a ladder and then stimulation went up high on its own (the pt is not using adaptive stim).The pt said he then went to turn stimulation off because the stimulation was high and subsequently saw a communication error of some sort.The caller states that the rep met with the pt on dec 22nd and a message on the tablet said 'the system detected that the device has been reset.Por.0x400'.Caller states everything looked fine with the pt's impedances.It was indicated that the patient may want to have the ins replaced.

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: 13060663
• MDR Text Key: 289901316
• Report Number: 3004209178-2021-18937
• 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: 01/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2021
• Date Device Manufactured: 01/21/2016
• 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: 59 YR
• Patient Sex: Male