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

Model Number 37602

Device Problems Energy Output Problem (1431); Communication or Transmission Problem (2896)

Patient Problems Dementia (1808); Twitching (2172); Cramp(s) (2193)

Event Date 10/13/2018

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 37602, serial# (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for parkinson¿s dual, movement disorders.It was reported that the patient was having dementia symptoms really bad that seemed to come overnight.The patient went to the er on (b)(6) and in the hospital they did all kinds of tests: a brain scan, urine test for uti, pneumonia, blood test, electrolytes, and everything was fine.The patient went home but did not get any better.The caller said the dementia could have been from medication the patient was using under their tongue.They put a couple of drops under their tongue to control drooling.The patient had not been using the medication for a while and they started to use it again.The patient checked their ins¿ with the programmer at home.One showed on and ok but the other ins showed poor communication.The caller did not know if it was the l or r ins that did not connect.On wednesday the patient went to see their neurologist and when they used their device over the ins¿ they were both fine.The doctor thought it might be an old patient programmer.The caller didn¿t have their programmer at the time but would call back to troubleshoot when the programmer was available.The caller reported the morning of the call that they started to have terrible jerking in the right side of their face and arms.It was the lower part of the face, shoulders, and arms.The patient went back to the emergency room and was there at the time of the call.While in there, the patient was also getting a cramp and started twitching/jerking again.They didn¿t know where the twitching came from, but their physical therapist thought it could be from laying in bed and not getting up.There were no further complications reported.

Event Description

Additional information was received: it was reported that the cause of the dementia symptoms and the other jerking symptoms was suspected to be overuse of their medication for drooling.To resolve the issue they stopped using the medication and had botox injections for the drooling.The issue had been resolved.There were no further complications reported.

Manufacturer Narrative

Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2017, product type implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for parkinson¿s dual, movement disorders.It was reported that the patient was having symptoms really bad that seemed to come overnight.The patient went to the emergency room on (b)(6) and in the hospital they did all kinds of tests: a brain scan, urine test for uti, pneumonia, blood test, electrolytes, and everything was fine.The patient went home but did not get any better.The patient checked their ins¿ with the programmer at home.One showed on and ok but the other ins showed poor communication.The caller did not know if it was the l or r ins that did not connect.On wednesday the patient went to see their neurologist and when they used their device over the ins¿ they were both fine.The doctor thought it might be an old patient programmer.The caller didn¿t have their programmer at the time but would call back to troubleshoot when the programmer was available.The caller reported the morning of the call that they started to have terrible jerking in the right side of their face and arms.It was the lower part of the face, shoulders, and arms.The patient went back to the emergency room and was there at the time of the call.While in there the patient was also getting a cramp and started twitching/jerking again.They didn¿t know where the twitching came from, but their physical therapist thought it could be from laying in bed and not getting up.There were no further complications reported.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 37602, serial# (b)(4), implanted: (b)(6) 2017, product type implantable neurostimulator.Correction to omit dementia (c4786) review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to the dementia symptoms the patient was experiencing.Therefore, this event will be reported for malfunction.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
• MDR Report Key: 8065022
• MDR Text Key: 126971680
• Report Number: 3004209178-2018-25328
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761064
• UDI-Public: 00613994761064
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR