MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Fatigue (1849); Complaint, Ill-Defined (2331)

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins) for dystonia and dbs therapy indications.It was reported it was taking them a long time to charge the ins.The caller stated that it concerned them that they don't see all the boxes filled up.The other day during charging the ins, they finally got all of the boxes shaded but that was the only time.No patient symptoms or further complications were reported as a result of this event.Additional information was received from a consumer.The caller requested clarification in understanding the recharging equipment.The caller reported the implantable neurostimulator recharger (insr) was indicating the ins was depleted and the patient needed to charge the ins.The patient mentioned trying to charge the ins the day prior which "took forever".During the call, the patient described the normal charge screen and confirmed the ins was off.The patient mentioned that might be why they were "more tired".The patient mentioned she charged the ins every day.The patient mentioned she had difficulty turning the antenna dial.It was reviewed the screens the patient was seeing were normal and the patient needed to let the ins charge before turning therapy back on.The patient mentioned her body was still adjusting to going back to what it was before the replacement.The patient stated she regretted getting a rechargeable ins.She could hear her insr clicking during recharging.It was reviewed this is a normal function of the insr.

Manufacturer Narrative

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

Event Description

Additional information received from the healthcare provider (hcp) reported the cause of the slow recharging and implantable neurostimulator (ins) depletion was likely due to the patient¿s high settings.According to the hcp the ins was changed from a primary cell to a rechargeable on (b)(6) 2018 which resolved the issue.No further complications were anticipated.

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.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: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8252691
• MDR Text Key: 133219912
• Report Number: 3004209178-2019-01091
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 99