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

Model Number 37603

Device Problems Migration or Expulsion of Device (1395); Device Difficult to Program or Calibrate (1496); Malposition of Device (2616); Communication or Transmission Problem (2896)

Patient Problems Muscular Rigidity (1968); Pain (1994); Shaking/Tremors (2515); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37603, serial#: (b)(4), implanted: (b)(6) 2019, product type: implantable neurostimulator.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

Information was received from a patient regarding an implantable neurostimulator (ins).The patient reported that their healthcare provider(hcp) "had one of the probes miss where it was targeted to." the patient explained that the hcp told them that the electrodes didn't miss the targeted area of the brain by a lot, but they "missed the area of the brain it's supposed to be in." as a result, the patient stated that programming the ins "became kind of a mess," noting that the hcp had difficulty with programming and the pandemic has made it difficult to get programming appointments.The patient then stated that the ins on the right side of their body "has fallen in the chest a little bit," noting that the ins is "sitting in fatty tissue of the breast." they also mentioned that they have trouble with the left side of their body.The patient explained that their tremors are "still pretty good, but not 100% under control." the patient added, "all the sudden i feel like i've aged 50 years.If every part of my body was made of rubber bands, they have tightened up so tight that it hurts to move.I'm cramping." the patient reported that they were trying to use the patient programmer to lower the level of stimulation, but they keep seeing the poor communication screen.The patient stated that they are getting the poor communication screen for both ins's.The patient was not using the antenna at the time.The patient services agent had the patient sync with each ins during the call, but they still got the poor communication screen.The patient was instructed to attach the antenna to the patient programmer.The patient attached the antenna and confirmed that they were able to sync with the ins on their left side, noting that the ins is turned on.However, they still got poor communication when they synced with the ins on their right side.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11135378
• MDR Text Key: 232587040
• Report Number: 3004209178-2021-00346
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864214
• UDI-Public: 00643169864214
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2020
• Date Device Manufactured: 11/14/2019
• 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: 60 YR