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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Delayed Charge Time (2586); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Vomiting (2144); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2023

Event Type  malfunction  

Event Description

It was reported that the patient has been having connection issues with the recharger since receiving the wireless recharger (wr).Patient states it will not stay connected to the implanted neurostimulator (ins).Agent asked if patient is using the drape and patient states yes.Patient confirmed they are able to make a connection to the wr but the connection is not lasting.Agent had the patient reset the wr on and off the docking station.The wr made a brief connection to the ins and disconnected.A replacement wr was sent.The caller stated that they have an old style recharger they still use but takes longer to charge the ins.Additional information received from the healthcare provider (hcp) reported they received the replacement recharger but continued to have connection issues when they tried to charge the implant as the recharger didn¿t stop beeping.The consumer was redirected to their healthcare provider (hcp) to check the implant and further address the connection issue.

Manufacturer Narrative

Other relevant device(s) are: product id wr9200, lot# serial# (b)(6) , product type recharger product id 37751, lot# serial# unknown, product type recharger.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.

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 received from the consumer reported they didn¿t know what led to the connection issue.The consumer received a new device the following day and the connection issue resolved.

Event Description

Additional information received, from the consumer.Reported, they continued to have difficulty charging the implant.As both the wireless recharger and legacy recharger took all day to get the implant fully charged.The consumer mentioned, the wireless recharger kept beeping regardless of where it was positioned.The patient met with their physician who checked the implant and told them everything was fine with it.However, the patient did mention, they lost about 100 pounds.And for probably two years at least, they could feel the implant sliding around in their chest along with poking them a couple of times.Which, felt like a stabbing sensation.During the call, the recharger made and maintained a connection to the implant, but at one point it lost its¿ connection and started beeping.But, the patient was able to get the connection back after they repositioned the recharger.The patient was scheduled to see their physician in november.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: wr9200, serial#: (b)(6), product type: recharger, product id: 97754, serial#: (b)(6), product type: recharger.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.

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 received from the consumer reported they continued to have difficulty charging the implant because the wireless recharger kept beeping.The consumer mentioned on october 10th their physician noticed the implant was turned off (the consumer didn¿t know their charge level when this was noticed).The patient said their hcp turned the ins back on, but the patient threw up right when it was turned on.The patient also mentioned that their managing hcp "found something about the nodule" when they were "adjusting the wave pattern¿.Information was repeated about the patient's weight loss and how they could feel the ins sliding around inside their chest.It was reviewed this could very well be contributing to their recharging issue, especially since the issue persisted after the wr was replaced.During the call, the wr intermittently disconnected from the patient's ins, but they were able to maintain a connection with it after repositioning the wr.The patient was advised to follow up with their hcp to further address the issue.

• 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: 17688978
• MDR Text Key: 322697230
• Report Number: 3004209178-2023-15404
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 09/19/2023; 09/25/2023; 10/23/2023
• Supplement Dates FDA Received: 09/25/2023; 09/29/2023; 10/27/2023
• Date Device Manufactured: 03/12/2019
• 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; SEE H10
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 125 KG