MAUDE Adverse Event Report: MPRI SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number B3300542M

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

Patient Problems Stroke/CVA (1770); Headache (1880); Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Loss of consciousness (2418); Confusion/ Disorientation (2553); Convulsion/Seizure (4406); Insufficient Information (4580)

Event Date 11/12/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was temporarily unresponsive to voice nor eyes as if catatonic.When asked what year he was born in, he was eventually able to answer.This incident lasted about three minutes.About 5 hours later manufacturer representative was informed that patient had another episode and had been confused about the date and said it was 2001.Patient was taken to the emergency room.Additional information was received stating the patient was admitted last night with seizures due to a small cortical bleed.His bleed has been stable on serial cts and measures 3cm x 1.5 cm.He is neurologically intact except for parkinson's disease sxs and he has having incontinence.It was reported that before his hospitalization he was having unresponsive spells, incontinency, and mild headaches.Family member reports taking his bp and he was in the 140 range, but in the er it was 169.He is now in the icu and normotensive and on keppra.He is getting his pd meds.Rep spoke with physician who provided a description of the bleed and its stability on cts done at 1am, 6am, and 9am.He did not know the reason for the extra scan.Stage 2 surgery on wednesday will be determined based on his ct and how patient does.

Event Description

Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the patient had a history of hypertension but it was believed that their blood pressure had been maintained after surgery.The diagnosis was considered a venous infarct which happened during the surgical procedure when the surgeon was opening the dura.The patient was being transferred to a rehabilitation center soon to work on some of their deficits related to the infarct.Some deficits include not being able to feed themselves and incontinence.It was unknown if the confusion 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: SENSIGHT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12832711
• MDR Text Key: 280936769
• Report Number: 2649622-2021-22971
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000426408
• UDI-Public: 00763000426408
• 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: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2023
• Device Model Number: B3300542M
• Device Catalogue Number: B3300542M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2021
• Date Device Manufactured: 10/07/2021
• 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 Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 75 KG