MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Low impedance (2285); Human-Device Interface Problem (2949)

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

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: product id: 3889-28, lot# va1zxgy, implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 28-may-2023, udi#: (b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.See regulatory report # 3004209178-2019-15105 for first ins/lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer¿s representative (rep) regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal /pelvic floor therapy.It was reported that the patient was undergoing an ins and lead replacement, and intra-operatively they were seeing <50 ohms with impedance testing despite widening parameters.Prior to calling technical support (ts) the hcp had already replaced the new lead and new ins.The second ins also showed <50 ohms impedance on c1 c3.Ts had the rep test outside the pocket and got all c combinations as 2053 ohms and the bipolars are fine.It was reviewed that those <50ohms may clear up later and use of the bipolar pairs is preferred for programming.Troubleshooting resolved reported issue and the hcp planned to close the patient.On (b)(6) 2019 the rep stated the product is performing as expected post-operatively.No further complications were reported or are anticipated.

Manufacturer Narrative

Product analysis (b)(4) analysis information -- 2019-09-25 12:37:05 cst pli# 30 product id# 3058 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The returned device passed all testing in the laboratory and no anomalies were identified.Pli#40 product id # 3889-28 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the outer insulation of the lead was twisted.Concomitant medical products product id 3058 (b)(4) implanted: (b)(4)2019 product type implantable neurostimulator product id 3889-28 lot# va1zxgy implanted: (b)(6)2019 explanted: (b)(6)2019 product type lead if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Conclusion code was corrected.Product id 3889-28, lot# va1zxgy, implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead.Section 'device' information references the main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 28-may-2023, udi#: (b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.See regulatory report # 3004209178-2019-15105 for first ins/lead.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The ins evaluation code-conclusion is 67.Product analysis #703261466:analysis information -- 2019-09-25 12:37:05 cst pli# 30 product id# 3058 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The returned device passed all testing in the laboratory and no anomalies were identified.Concomitant medical products: product id 3058 lot# serial# (b)(6).Implanted: (b)(6) 2019 explanted: product type implantable neurostimulator product id 3889-28 lot# va1zxgy serial# implanted: (b)(6) 2019.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.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.

Manufacturer Narrative

Correction to h6: evaluation code-conclusion for the lead is: 4315 product analysis #703261466:analysis information -- 2019-09-25 12:37:05 cst pli# 30 product id# 3058 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The returned device passed all testing in the laboratory and no anomalies were identified.Pli#40 product id # 3889-28 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the outer insulation of the lead was twisted.Continuation of d11: product id 3058 lot# serial# (b)(6) implanted: (b)(6) 2019 product type implantable neurostimulator product id 3889-28 lot# (b)(6) implanted: (b)(6) 2019 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.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: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8867821
• MDR Text Key: 153803881
• Report Number: 3004209178-2019-15106
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Date Manufacturer Received: 10/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR