MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37612

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins).The reason for call was the caller reported that the patient has bilateral rc and the patient is not able to connect to the right side ins for charging.The ins is 75% charged.The patient (pt) had a "wound revision" last tuesday.Rep indicated that since the revision the patient has not been able to connect to the ins.Recharger showed solid green then disconnects shortly after.Technical services (tss) discussed checking implant orientation with x-ray to make sure header block is facing the spine since neurostimulator is on the right.Discussed how angle of the neurostimulator can affect recharging as well.Tss suggested getting pa/ap view and a lateral view to check implant position.Tss also suggested getting another recharger to try if possible.Tss made sure rep was only using the recharger app, rather than using the clinician app or patient app while trying to connect to the recharger.Rep stated the right ins when implanted was at 75% and is now at 50% and the pt indicated that they did try charging the ins with the insr as well but was getting the same results of not connecting to ins.Rep asked for recharge interval calculation based on the following settings: right ins: 4.4v, 90, 160 hz 726 ohms low 25%: 13.83 days, empty 0%: 2.63 wks.Tss provided information.There is no issue charging the left side.Rep stated that surgeon stated they did implant inss deeper but surgeon felt at the same depth as well due to issue pt was having with the inss popping out of pocket.Pt will be back in for follow-up next week with surgeon.They are hoping that the swelling will go down more by that time as well.The issue was not resolved.Refer to manufacturer report 3004209178-2022-10657 for related device.

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 manufacturer representative (rep) that the revision on 8/23 resolved the connection/charging issues on the right side.The cause of the issue was the generator had flipped in the pocket.In the revision, the generator was turned around to face the correct way and the patient¿s ability to charge was confirmed.Thus, the issue appears to be 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.

Event Description

Additional information was received from the manufacturer's representative (rep) who reported that the right side ins with the legac y recharger shows no coupling bars.The ins cannot be palpated.The cause of being unable to connect to the right side ins was not determined, and the charger was still not charging the patient's implant on the right side with the wireless recharger or the legacy recharger.The patient is scheduled for a pocket revision to move the generator more to the surface of the patient's chest.Clarification of the report of the inss popping out of the pocket was that the patient is very thin and the surgeon initially placed the generators deeper under the tissue as they seemed very superficial.Per the rep, the surgeon described "popping out of the pocket" which meant very superficial.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15267665
• MDR Text Key: 298375173
• Report Number: 2182207-2022-01613
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• 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,Followup,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2022
• Date Device Manufactured: 09/08/2014
• 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 Sex: Female