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

Model Number 37612

Device Problems Electromagnetic Interference (1194); Loss of Data (2903); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

Codes are associated with lead.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Other relevant device(s) are: product id: 3389-40, serial/lot #: (b)(4), ubd: 25-aug-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported post-operatively, following a lead revision, when interrogating the ins it was discovered that the ins had been completely reset and all the stimulation settings and patient information was wiped.The patient underwent a left brain lead surgical revision.The ins was on during parts of the procedure to test the electrode impedances.Monopolar diathermy was used intermittently throughout.When looking at the session reports, it was noticed the implant date post-operatively was incorrect and set to (b)(6) 2000.The device was implanted on (b)(6) 2019.The ins settings and patient information was re-entered and the neurostimulator was set up.All of the electrode impedances and therapy checks were within normal range.The issue was resolved at the time of the report.

Manufacturer Narrative

B5/h1: additional information indicated the lead revision was a re-implant procedure for a previously reported event.See report number 3007566237-2019-01697.Serious injury no longer applies to this event, however it remains reportable for a malfunction.B2: adverse event no longer applies.Updated to product problem.H6: device code c53269 no longer applies.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: 9444306
• MDR Text Key: 170152736
• Report Number: 3004209178-2019-23465
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR