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

Model Number 37612

Device Problems High impedance (1291); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Shaking/Tremors (2515); Electric Shock (2554); Unspecified Nervous System Problem (4426)

Event Date 05/13/2021

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 had a fall several weeks prior and gets "shocks" when he turns his head to the left or right.Caller reported this is also related to the instance of the patient "bumping his head" and patient had reported that from this, he "lost all control of his right hand" and had a terrible tremor in his right hand.Caller noted that when she adjusted the patient's stim- turned it off or turned it up-he didn't feel it made any difference.  agent asked several times for event date: caller stated (b)(6) 2020 at one point but also stated that the pt  the fall happened several weeks ago prior to (b)(6) 2020. caller noted that in (b)(6) 2020 pt reported that he still has little control in his right hand but complete tremor control in his left.

Event Description

It was reported that the patient had a fall several weeks prior to (b)(6) 2020 and gets "shocks" when he turns his head to the left or right.They reported this is also related to the instance of the patient "bumping his head" in which the patient "lost all control of his right hand" and had a terrible tremor in his right hand.When they adjusted the patient's stimulation (turned it off or turned it up), he didn't feel it made any difference. in (b)(6)-2020, the patient still has little control in his right hand but complete tremor control in his left.The healthcare provider (hcp) indicated that the patient needed an mri but they were worried about their scan eligibility as the last few times they had checked their impedances values were high (this was typical for the patient).On (b)(6), 2021 values were 2,052 and on (b)(6) 2021 2 ,090, and on (b)(6), 2021 they were 687.On (b)(6) impedance testing was performed with values in the normal range (1,039).Additional information was received from a healthcare provider (hcp) reporting that on 2020-(b)(6), the patient reported a fall, felt shocks, and impedances were within normal limits on 2020-(b)(6).The cause of the high impedance was that the patient had hit his head during the summer and his tremor in this right hand returned.The patient was referred to neurosurgery for consult, the ins was replaced and impedances were within normal limits.

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: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 12866804
• MDR Text Key: 281202948
• Report Number: 3004209178-2021-17543
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000100360
• UDI-Public: 00763000100360
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/08/2021
• Date Device Manufactured: 09/04/2020
• 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
• Patient Age: 51 YR
• Patient Sex: Male