MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number B35200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Pain (1994); Pallor (2468); Shaking/Tremors (2515); Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that the patient's ins reached eos and programming information was lost as a result.The patient indicated that they experienced a return of symptoms, which became worse after their ins was replaced.When they were taken out of surgery after the device was implanted, the patient stated their whole body was shaking and the "numbers were way off".The patient stated that a manufacturer's representative (rep) was present when the device was implanted and helped with programming.The patient stated that the rep told them it may take a while for the patient's condition to improve.On saturday, the patient stated that they took off the dressing from the implant site, then ended up going to the emergency room on saturday because the battery for was sticking out of their chest, was pushing their skin out "pretty far ," and the affected area turned white.The patient stated that they have an appointment with their surgeon today, and a programming appointment with their neurologist this thursday.The patient was redirected to their healthcare provider to further address the issue.Additional information was received.It was reported by the consumer that the repot of the "numbers were way off" was that upon waking their program was set at 4.2.They advised the rep and started lowering it.It was around 1.5-2.0 and the rep told the patient to stop and let it stay at 4.2.The circumstances that led to the battery sticking out of the chest/pushing their skin out was that it was one of the wires.After taking off the dressing, it was clearly protruding and pushing the skin so tight the skin was white and the protrusion was catching on the patient's clothes.The swelling from surgery was gone but the wire was still protruding.There were no steps taken to resolve the issue so far.They went to emergency room.And had an x-ray.They stated the surgeons office pa but a band aid on it.The issue was not resolved at this time and the patient is meeting with their surgeon on 4/8 for another post up follow up.Additional information was received from the consumer who repeated information that the patient stated that the ins implanted on march 24th resulted in a wire protruding from their chest that they noticed on march 26th when they removed their dressing.The patient repeated that the skin of the protrusion was white, and stated the wire itself wasn't sticking out of the skin, and that they can almost see the battery (ins).The patient also added that the percept implant was smaller than the one prior, and that the surgeon gave them a bigger pocket on the left side as the right side uses more energy, and thus, the pocket should've had enough room for the device.The patient mentioned they went to see their surgeon's pa on the 28th of march, but that the pa did not want to mess with the implant site.The patient then met with their surgeon on april 8th, and was advised to meet the surgeon at the emergency room on april 9th.The patient stated the revision (wire was sutured back down) was performed, but that the issue was not resolved, as the wire is again protruding and the patient is experiencing pain in their chest while moving, as well as when they move their arm.The patient stated they have an appointment with their surgeon this friday (june 3rd) to further address the issue, and patient stated they assume there will be another surgery.

Manufacturer Narrative

Other relevant device(s) are: product id: neu_unknown, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the hcp who reported that the cause of the wire/battery protruding was due to excessive scarring related to multiple injuries.Further action is planned for further exploration.

Manufacturer Narrative

Concomitant medical products: product id 37601 serial# (b)(6) implanted: (b)(6) 2020 explanted: (b)(6) 2022 product type implantable neurostimulator product id neu_unknown serial# unknown product type unknown.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: PERCEPT
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 14594970
• MDR Text Key: 293289854
• Report Number: 3004209178-2022-07136
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00763000519216
• UDI-Public: 00763000519216
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• 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: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2023
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2022
• Date Device Manufactured: 08/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: "SEE H10."
• Patient Outcome(s): Required Intervention
• Patient Sex: Male