MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ITREL II; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7424

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pocket Erosion (2013)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 7495-51, serial #: (b)(4), implanted: (b)(6) 1992, explanted: (b)(6) 2019, product type: extension.Product id: 3487a, lot #: l20179, implanted: (b)(6) 1992, explanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 7495-51, (b)(4).Product id: 3487a, serial/lot #: (b)(4), ubd: 20-may-1995.Device evaluated by mfr: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care professional regarding a patient who was implanted with a neurostimulator.It was reported that there was an exposed wire and generator, so the stimulation system was removed on (b)(6) 2019.The patient recovered without sequela.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the healthcare provider (hcp) reported the patient¿s weight at the time the device was explanted.No further complications were anticipated.

Manufacturer Narrative

H3: analysis of the neurostimulator (ins), serial number (b)(6) found the stimulation ins battery was at normal end of life with no telemetry and no output.Analysis of the extension, serial number (b)(6) found the stimulation extension body was cut through and segmented.Analysis of the lead, lot number l20179, found the stimulation lead proximal end was stretched.Section d information references the main component of the system and other applicable components are: : product id: 7495-51, lot# serial# (b)(6), implanted: (b)(6) 1992, explanted: (b)(6) 2019, product type: extension.Product id: 3487a, lot# l20179, implanted: (b)(6) 1992, explanted: (b)(6) 2019, product type: lead.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.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: ITREL II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8850904
• MDR Text Key: 152945336
• Report Number: 3007566237-2019-01685
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 7424
• Device Catalogue Number: 7424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 08/13/2019; 10/30/2019
• Supplement Dates FDA Received: 08/28/2019; 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 59