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

Model Number 37603

Device Problems Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Dysphasia (2195); Complaint, Ill-Defined (2331); Electric Shock (2554); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported they inquired if the patient will get a percept device when the implantable neurostimulator (ins) is replaced.They hope the percept will last longer than activa.They mentioned these implants only lasted 3 years compared to the implants before which had lasted 4 years.They stated 3 years ago when the last ins was changed out, the person took the "readings"/settings from the old battery and put them on the new battery, this implant setup.The new battery was putting out a greater charge/gave the patient a jolt because the caller had raised the settings before the implants were replaced in 2017, and this caused the patient a lot of problems.After surgery, the patient had speech problems, it was like the patient's brain was being fried from being overcharged.They stated the patient was really hurting after surgery and had to lay down in the car.The patient was being jolted at 2.9, they turned it down, and the patient recovered.When the battery started to get low, they backed down the battery settings for 6 days straight to conserve the battery.The patient has an appointment tomorrow and will talk to the physician to make sure this does not happen again when the next battery needs to be replaced.

Manufacturer Narrative

H6.The codes have been updated to reflect the most current coding.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 10566787
• MDR Text Key: 208015027
• Report Number: 3004209178-2020-16417
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761088
• UDI-Public: 00613994761088
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR