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

Model Number 37612

Device Problems High impedance (1291); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Manufacturer Narrative

B3: event date is not known.Please see b5 for approximate date range, if applicable.Continuation of d10: product id wr9200 ; product type: 0213-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.

Event Description

Information was received from a healthcare provider (hcp) regarding an implantable neurostimulator (ins).The reason for call was caller stated patient (pt) was in office last week and noted it was taking a long time to charge the ins and ins was depleting quickly.Caller stated they checked impedances and discovered one contact was "avoid" with high impedances but that contact was not active in programming.Caller stated patient returned to office yesterday, with recharger, for further troubleshooting and patient's wife stated they had to charge for 4 hours the night before.Caller indicated that patient's wife stated that recharging is better when the patient is lying flat but even then, it seemed to not be working.Caller provided the recharge stats from both last week's session report and yesterday's session report:last week's interrogation (median coupling 6 boxes)1/25 50% 4 minutes1/26 50-75% 1.18 hour1/29 25-50% 31 minutes1/29 50-75% 1.36 hours1/30 50-75% 1.9 hours1/31 75% 37 minutes.Yesterday's interrogation (median coupling 7 b oxes)2/5 50% 8 minutes2/5 50% 8 minutes2/5 50% 11 minutes2/6 50-75% 1.77 hours2/6 50-75% 27 minutes.Tech services (tss) reviewed general wireless recharger (wr) information and use; specifically around light and sound indictors as patient doesn't use a handset.Tss reviewed that it appears that wr may be connecting and disconnecting so that patient's wife thinks that the ins is recharging but it isn't.Caller was going to review this information with patient's wife and monitor the issue.No symptoms reported.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information received from the consumer reported it was taking 2-4 hours to charge unless they were lying flat as they couldn¿t keep the connection.The patient saw their physician and the manufacturer representative (rep), but they didn¿t see a problem, and the issue wasn¿t resolved.

• 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: 18687144
• MDR Text Key: 336228050
• Report Number: 3004209178-2024-04466
• Device Sequence Number: 1
• Product Code: MHY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Date Device Manufactured: 03/17/2018
• 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: Male
• Patient Weight: 73 KG