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

Model Number 37601

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Electric Shock (2554)

Event Date 09/04/2019

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 healthcare provider via a manufacturing representative about a patient with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the after the patient received a new ins, they began to experience electrical sensations more than 20 times a day.Mostly on the left side of their body.The patient also had sever on/off symptoms both with their parkinson's medication and when medication was changed.The patient stated that it was as if they couldn't understand their body any more, they were out of control.Palpating the device pocket and manipulating the device did not provoke any symptoms.The patient felt that their body did not feel okay, as it did prior to receiving this ins.The ins was explanted and replaced, resolving the issue.The patient is now back to normal, and they are even taking less medication than before.No further complications were reported or anticipated.

Manufacturer Narrative

Additional patient codes added per additional information from event description.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was noted the patient had never had off-symptoms with dbs, and the off-symptom severity and quantity could not be managed with medications, as the medications could not meet the patient's disease severity.The patient also experienced bad sleep for the past month and slower movement, but there were no shaking symptoms.The patient's parkinson's state was still not good with the combination of dbs treatment and use of more drugs than before the first or second ins replacements, but the patient was sleeping well again.The cause of the electrical sensations was not determined, but the sensations were resolved after replacing the ins.

Manufacturer Narrative

H3: analysis of the ins (serial no.(b)(4)) found no anomaly.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: 9269263
• MDR Text Key: 164710327
• Report Number: 3004209178-2019-20915
• Device Sequence Number: 1
• Product Code: MHY
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR