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

Model Number 37612

Device Problems Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927); Positioning Problem (3009)

Patient Problems Scar Tissue (2060); Tissue Breakdown (2681); Swelling/ Edema (4577)

Event Date 12/08/2020

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 surgery on tuesday to remove scar tissue that was built up around her ins.The patient mentioned that ever since then, they have been unable to get any coupling boxes shaded in on their recharger.The patient started a charging session and moved the recharger antenna around the implant.The issue was not resolved through troubleshooting and a replacement recharger antenna was sent.Additional information was received from a manufacturer representative (rep) reporting the patient had revision approximately 10 days ago.The revision was to create a new pocket for the implantable neurostimulator (ins) in the same general location.The ins is located in the left chest.The patient is a small frame woman.They are assessing the recharging.The coupling on the recharger goes from 2 bars down to zero bars.At one time, they indicated seeing 4 coupling bars.The wireless recharger (wr) was also used with the same issue.It would find the ins and then lose the connection.X-ray did indicate the ins was not flipped.It was discussed that since this issue was occurring with multiple rechargers, the issue must be with the ins and with a depth or swelling issue.They were recharging directly over the skin and the ins is superficial, but did indicate there was some swelling.It was recommended to wait a little longer for the wound to fully heal.

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 manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the circumstances that led to the pocket revision/scar tissue removal was due to tissue breakdown at the implantable neurostimulator (ins) site.There were no issues with the device or therapy.The cause of the coupling issue was due to the ins possible being placed too deep after the pocket revision along with significant swelling at the ins site.After the wound was fully healed the patient was able to get two bars and recharge.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11084323
• MDR Text Key: 224036368
• Report Number: 3004209178-2020-22655
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR