MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number B35200

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Loss of Data (2903)

Patient Problems Headache (1880); Loss of Vision (2139); Dysphasia (2195); Ambulation Difficulties (2544); Electric Shock (2554); Paresthesia (4421)

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id b35200 lot# serial# (b(6) implanted: 2022-05-19 explanted: product type implantable neurosti mulator product id tm91d0 lot# serial# npe038300n implanted: explanted: product type product id hh90d01 lot# serial# unknown implanted: explanted: product type mobile platform 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.

Event Description

It was reported that the patient's implantable neurostimulator (ins) is off but the patient (pt) thinks their ins is still on.Pt feels a shocking sensation. pt thinks the communicator is still connected to the ins.Pt thinks there is something wrong with the communicator because the communicator started an update and the pt turned it off before the update was complete.Manufacturing representative (rep) provided the following follow-up information: rep said his co-worker met with the patient (pt) today and all the impedances were fine.The rep confirmed the ins was off.The healthcare provider (hcp) had the rep remove all programs.Pt thinks there is something wrong with the communicator because it flashes sometimes and the pt insisted that he be sent a new communicator. the caller states that the pt also believes there may be an issue with their handset thought it is unclear what it is -- agent advised that if there is a problem with the handset, the pt should go through patient services (pss) to get to hcit to clear the phi from the handset first.Caller understood.The caller also noted that the pt believes their stimulation has caused them to go blind in one eye (unknown which eye) and that started 'months ago' and rep was notified today. pss received call from mobility with the patient on line.The caller was alleging that when mobility asked them to turn the handset on " everything came back , even though the communicator was not on".The caller started to allege symptoms of dysarthria, paresthesia and a headache that came on very suddenly.The caller believes these symptom's happened by simply turning the handset on without the tm91.The caller stated that all of these terrible symptom's came back when the handset was powered on , but was not using the tm91 when powering the handset on.The caller stated that when the reps interrogated the ins this morning , and it also made the patients symptom's come back.The caller stated that this morning the programmer erased all the programs.The caller also reported difficulty walking up and down , and stating now that their speech is abnormal.When pss asked the caller what they were seeing on the handset , the caller stated that the handset is powered off. pss called and spoke to a rep to provide further clarity on the situation.The rep confirmed that the patients ins is off, and stated that they have been through this several times over the last few days with the patient.The rep stated that they have met with the patient several times in person to explain how the equipment works , and to provide reassurance that the ins is turned off.The rep stated that the tm91 is also turned off.The rep stated that the hcp is aware of the issue , and that the patient is adamite on replacing the handset.The rep stated that the patient is seeing the hcp next week , and the hcp was the one who asked the reps to connect and verify the ins is turned off.The hcp has also communicated to the patient that the ins is turned off.Due to the nature of the call pss sent a replacement handset , and redirected the patient to the hcp to further address the symptom's they are experiencing.Per the rep - the patient is not suppose to use/power on replacement equipment until next week when they meet with the h cp. pss explained to the patient that the handset and tm91 have already been requested to be replaced.The caller stated that they are in a medical crisis due to mobility asking the patient to turn the handset on.The caller was demanding that "someone come over now and turn this off".Pss attempted to explain the the reps work under the supervision of the hcp.The caller confirmed that the handset is powered off.The caller stated that whatever the rep did this morning worked, and needed to dealt with now/immediately.Pss advised if the patient feels like they are in need of immediately medical attention , to call the doctor to further seek medical advice.Additional information was received from the manufacturing representative (rep) stating that it is unknown if the issues above were related to the device, therapy, or implant procedure as the devices seemed to be working as they should within normal impedances.The cause of the shock was not determined.The rep met with the patient last week again, under the direction of the managing neurologist.The impedances were normal, and there were no programs in the generator.The patient initially believed that the device was somehow still on because he had only mild tremor in his left hand while he typically had more tremor at baseline.His right hand had its typical tremor.At one point after the rep let him know that the device showed as being complete off on my end, he said he needed to walk around to see if there was any change in the side effects he had had experienced.When he walked away, he reported his left hand began to ¿tremor more¿, so he believes that when he walked away from the clinical tablet and communicator that the device was shutting off, but when he got close to it again that the device was on.Again, the device showed as completely off on the clinician tablet.The patient reported that the side effects he was experiencing before (paresthesia in his legs, shocking in his head, etc) he was no longer feeling after this meeting.

• Brand Name: PERCEPT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 18756783
• MDR Text Key: 335943693
• Report Number: 3004209178-2024-05439
• Device Sequence Number: 1
• Product Code: PJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2024
• Date Device Manufactured: 07/13/2022
• 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
• Treatment: "SEE H11...."
• Patient Sex: Male