MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37601

Device Problems Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: neu_unknown_lead, serial# unknown, product type lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient felt like their parkinson's symptoms were worse and that their parkinson's medications were not working very well.Prior to this event, the patient stated that they were dealing with covid-19 for the past 3 weeks, had to go to the er twice (related to covid-19) during that time frame, and returned home this past friday.While they were in the hospital, the patient stated that they had to get 2 ekgs, and they noted that the ekg provider used the patient programmer turn therapy off then back on for each ekg.The patient remembered the ekg provider dropping the patient programmer on the ground.One of the patient's healthcare providers told them that covid-19 could have made their parkinson's symptoms worse, and that it could be a couple of months until they resume "normal conditions." the patient stated that their symptoms are "probably covid" related and not related to their parkinson's because they "don't feel any brain stimulation weirdness." after the patient returned home this past friday, they mentioned that they "pulled" their back when they hung a tree swing and had severe back pain all weekend.On that same friday, the patient stated that they were trying to check their ins with the patient programmer, but they kept seeing the 'poor communication' screen.As a result, therapy status could not be confirmed.The patient stated that they replaced the aaa batteries and tried syncing without the antenna, but the 'poor communication' screen persisted.Due to the persistence of the 'poor communication' screen, the patient thought they "maybe pulled the cord loose" (agent was under the impression the patient was referring to the dbs lead and/or extension) as they were hanging the tree swing.However, the patient mentioned that their ins was implanted in their abdomen and they did not indicate that they felt pain near the implant site.The patient stated that they called their healthcare provider to report the 'poor communication' screen issue, but they advised the patient to call them back today.The patient stated that they called patient services before calling their healthcare provider again.The patient confirmed they were using appropriate batteries in the patient programmer.As noted earlier, they did mention that the ekg provider at the hospital dropped the patient programmer, but no damage was reported.

• Brand Name: ACTIVA
• 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: 12872574
• MDR Text Key: 286760953
• Report Number: 3004209178-2021-17604
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2021
• Date Device Manufactured: 03/20/2019
• 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 Age: 57 YR
• Patient Sex: Female