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

Model Number 37603

Device Problems Break (1069); Unintended Collision (1429); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994)

Event Date 05/26/2018

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 regarding a patient with an implanted neurostimulator (ins) for parkinsons dual and movement disorders.The patient reported seeing an out of regulation (oor) message on their patient programmer.The patient reported they went to their healthcare provider (hcp) to have the ins programmed about 1.5 weeks ago.The patient reported seeing an oop message.The patient reported that during troubleshooting they initially got a poor communication screen and the patient stated they forgot they needed the antenna.The patient then reported they were able to connect and confirmed the patient programmer showed an oor messaged, not an oop.The patient reported that the oor did not come up on their left ins, and only showed up on their right ins.The patient reported that they had group a and group b on the right ins.The patient reported having a fall about 3-4 weeks ago but they stated they got it checked out with a ct scan and made sure everything was working right.The patient also reported experiencing pain from dystonia.The patient reported going to take a bath and they were in a lot of pain.The patient reported checking their ins to make sure it was on and stated the patient programmer showed the ins was on.The patient reported they were not adjusting settings when the oor message came up.The patient reported turning stimulation off and back on did not resolve the issue.The patient reported they were now on group b and would stay on that group until they saw their hcp again.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient indicating that 2 weeks after the oor message they went back to the hcp and they reported the lead was no longer working.Issues have not been resolved.Patient reported right side lead broke and they experienced pain in left side of body.Patient didn't know why their lead would break so easily and when asked if the healthcare provider said the lead broke, the patient said no that the doctor said that "it (lead) wasn't working." patient said they were wondering why the material in the device was still being used if it was so easy to break.Adverse events in labeling was listed to the patient and lead fracture being one/activity restrictions.Patient said that was difficult because patients are being told to exercise and they were sure lots of patient's with pd fall a lot.Patient said their batteries were not placed in their chest, they were in their abdomen so the wires are longer and less restrictive.To seek clarification the cat scan was done and everything was fine and nothing had moved so the patient didn't understand why all of a sudden nothing was operating on that lead (the 2nd connector).She was told brain surgery was the only option.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Section information references the main component of the system and other applicable components are: product id 3389s-40 lot# va1lwek serial# implanted: 2018 (b)(6) explanted: product type lead product id 3389s-40 lot# va1nw57 serial# implanted: 2018 (b)(6) explanted: product type lead product id 37603 lot# serial# (b)(4) implanted: 2018-(b)(6)explanted: product type implantable neurostimulator : due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient reporting that their second lead was not working "which means brain surgery again." the patient reported they did not understand why the quality was not as good with the wiring system.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7557280
• MDR Text Key: 109675391
• Report Number: 3004209178-2018-12239
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761088
• UDI-Public: 00613994761088
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 02/28/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 57