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

Model Number 37612

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Twitching (2172); Dysphasia (2195); Neck Pain (2433); Tics/Tremor (4425); Intervertebral Disc Compression or Protrusion (4524); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The event date is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported they are due to get the implantable neurostimulator (ins) replaced with a non-rechargeable ins on (b)(6) 2020 due to the ins being well short of its expected longevity.The patient stated the rechargeable ins did not perform as well as the non-rechargeable inss.They explained it was like two years that they have been dealing with it and it did not make their body and brain feel as good as the other generator did.Now they have vocal ticks back and motor ticks.They have contorted and twisted so hard within this year that they popped a lower lumbar herniated disc out and had to have emergency surgery due to that.Before they had the deep brain stimulation (dbs), they used to "contort, jerk, and twist really hard" for years.The rechargeable ins did not perform as well as the non-rechargeable inss in managing their symptoms.The patient told their healthcare provider (hcp) that they cannot deal with it anymore.They are hurting their neck, getting migraines, and just do not feel as well as they did using the rechargeable ins.

• 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: 10983380
• MDR Text Key: 220662061
• Report Number: 3004209178-2020-21552
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Date Device Manufactured: 08/12/2016
• 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