MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Low impedance (2285); Battery Problem (2885); Charging Problem (2892)

Patient Problems Tingling (2171); Malaise (2359)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for the treatment of dystonia and movement disorders.It was reported they were charging too often.The patient sated she was charging the right implant about every 3 days vs every 4 days which was different than before.The patient reported she would charge both of her inss every 4 days.She stated she charged her right ins the night prior but could not tell what the battery level was at the morning of the call because she was seeing the oor.The patient charged her ins and, when check on the call, it was 100% and on.It was noted the patient was seen (b)(6) 2019 with the managing hcp and the patient was not aware of any programing changes other than they checked "the wire" and everything was fine.No parameter increase or over discharge events were reported.The patient had an upcoming appointment on (b)(6) 2019.No trauma/falls, unrelated medical procedures, or emi were reported to be related to the issue.The patient reported not feeling the best prior to or around (b)(6) 2019 when she went to the hcp.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer reporting that the impedances were checked and 0-2 pair is 54 ohms, all other impedances are normal and therapy impedance ins 954 ohms.Caller reiterated that the ins was draining quickly - right is on 50% of the time, left is on 100 % of the time.Caller provided right settings as 0- 1- 3+ 3.3v, 150 pw, 220 rate.Caller inquired why oor keeps coming up on the programmer and patient has to keep clearing it.Caller stated that today, patient reported intermittent tingling at connection site behind right ear that comes and then goes quickly, patient didn't specify if it was positional or not.

Manufacturer Narrative

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 cause of the short wasn't determined.No further complications were anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative (rep) reviewing that the oor is generally caused by the short.They stated the patient will have a revision on (b)(6).

Manufacturer Narrative

D2: please note that this device was used in an off-label manner as it was implanted for dystonia.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.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8745787
• MDR Text Key: 150262219
• Report Number: 3004209178-2019-12647
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/10/2020

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: 12/14/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 07/11/2019; 08/07/2019; 08/28/2019; 11/10/2020
• Supplement Dates FDA Received: 07/24/2019; 08/26/2019; 09/10/2019; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Weight: 45