MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Low impedance (2285); Delayed Charge Time (2586); Battery Problem (2885)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that manufacturer representative (rep) got an email from hcp reporting patient having impedance issue, although it doesn't appear to affect any symptom.Patient has device for depression.Issue is on the left implant.No report of fall or trauma.Patient reported device turning itself off 3x in the last 4 months and the left side is taking 3x as long to recharge compared to the right.Based on therapy impedance of 63 ohms at 41ma, it appears that patient is draining the battery very fast thus causing longer recharge time and perhaps cause of therapy turning off.Patient saw hcp on jan.20th.Impedance check on patient's previous visit didn't have impedance issue; rep didn't know when patient had the previous visit with hcp.1-2+ 130hz 90pw 4 volts 63ohms, and 41.0 ma 3 1021 ohms 2 682 1 685 0 2649 3 0 3329 3 1 1145 3 2 1126 2 0 2297 2 1 63 0 1 2297 ohms technical services(ts) advised using other electrode combinations to program, rather than 1 2 since there is a short circuit.If programming can't resolve the issue then a revision may be needed.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.No symptoms were reported.

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.

Event Description

Additional information was receiving from the rep via email from hcp.It was reported following the report in january, patient was reprogrammed off low impedance pair to 0-3 and noticed that charging time improved but patient's mood still isn't back to baseline.Caller read from hcp's email that c-0 is 2521 ohms and "total impedance" increased by 1000 ohms since last visit 3 months ago (tech services (tss) and caller took this to mean that therapy impedance increased).Hcp noted that patient has more fibrosis on left lead but patient hasn't reported any issues/symptoms related to this.Hcp inquired if they should leave patient programmed on 0-3 and increase amplitude from 2v to 3v or reprogram to c-3.Tss reviewed we wouldn't be able to provide specific programming recommendations and there would be pros/cons to both configurations related to potential therapy change and charging frequency.Caller was going to email hcp today and then speak with them in person this week.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 13345288
• MDR Text Key: 291414003
• Report Number: 3004209178-2022-01155
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2022
• Date Device Manufactured: 01/23/2013
• 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 Sex: Female