MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37603

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 11/24/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: 3387s-40, serial/lot #: unknown.Product id: 3387s-40, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the dbs therapy helped the patient with the pain from dystonia when their first dbs system was implanted, but about a month later they started to notice the pain again.The patient stated that their pain level was a 12 out of 10 at that time (10 being the most pain).Then, the patient stated that their healthcare provider (hcp) realized "after the second implant, that they put the first one in the wrong place." the patient confirmed that they were referring to leads.The patient stated that they had to go in for surgery 3 times to address the lead placement issue, noting that the last surgery was in 2017.However, the patient stated that their symptoms did not get any better until "maybe the end of 2020" or beginning of 2021.The patient stated that they have been doing "very good" for the last year and 3 months, and that 2022 has been good so far.The patient stated that their pain level went down to a 1 out of 10.The patient mentioned that they do notice "a little bit of slipping," but they get botox injections in th eir neck muscle every 3 months, which helps.Due to the nature of the call, agent did not ask the patient to clarify what they meant by "slipping," but agent was under the impression they were referring to fluctuations in their pain level. .

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.

Event Description

Additional information was received from the consumer.It was reported that the current status of the affected devices is that the patient thinks they used the same device and repositioned it.The issue of the lead replacement has resolved.The patient reported that as of today ((b)(6) 2022) they feeling better, and they are off all prescribed pain meds and now take advil and tylenol daily.The pain from dystonia seems to be under control.

• Brand Name: ACTIVA
• 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: 13791294
• MDR Text Key: 290167139
• Report Number: 3004209178-2022-03376
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• 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: 04/05/2022

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: 03/14/2018
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 04/05/2022
• Date Device Manufactured: 09/26/2016
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 68 KG