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

Model Number 3058

Device Problems Break (1069); Unable to Obtain Readings (1516); Connection Problem (2900); Impedance Problem (2950)

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

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3023, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.Other relevant device(s) are: product id: 3023, serial# (b)(4), ubd: 2012-04-28, udi#: (b)(4).The related ins s/n: (b)(4) will be submitted in a separate report and that reg.Report number will be provided in subsequent supplemental reports.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer¿s representative (rep) regarding a patient undergoing an implant of a neurostimulator (ins) for gastrointestinal /pelvic floor therapy.It was reported the ins was being replaced due to normal battery depletion and there was lead insertion difficulty reported during procedure.The hcp removed the existing ins and extension and when attempting to insert lead into new ins ((b)(4)) the lead would not fully insert into the header.The rep states physician pulled the lead out, cleaned it off and attempted to insert again with no resolution.Physician then turned ins setscrew quarter turn to left but lead still wouldn't pass through.Caller states they tried this 5 times with no resolution.Physician then used another ins ((b)(4)) and encountered the same issue.At this point, physician determined it was a lead issue and inserted the lead as far as it would go and tightened and torqued the setscrew down.Caller states impedances were checked and 3 of 4 electrodes were fine and physician was satisfied with this and closed the patient.Technical services (ts) reviewed that the lead end may have been damaged from overtightening of hex wrench at the lead/extension connection.Patient is currently implanted with existing lead and (b)(4).Ts reviewed that contacts can become misshapen when tightening screws on at extension/lead site and suggested rotating lead when inserting into header block in the future.There was no visible damage to the lead, the rep examined the lead in the field and didn't see any issues.The rep had the ins that was not implanted and planned to return it for analysis.No symptoms were reported and no further complications were reported or are anticipated.

Event Description

Additional information was received from the manufacturer¿s representative (rep): the rep not believe an out of box failure was foun d in either ins.No symptoms were reported and no further complications were reported or are anticipated.

Manufacturer Narrative

Product id 3889-28 lot# serial# (b)(4), implanted: (b)(6) 2011explanted: (b)(6) 2019 product type lead related ins s/n njy439396h was submitted in reg.Report # # 3004209178-2019-07850 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

Concomitant medical products: product id 3889-28, serial# (b)(4), implanted: (b)(6) 2011 explanted: (b)(6) 2019 product type lead related ins s/n (b)(4) was submitted in reg.Report # 3004209178-2019-07850.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.

Event Description

Additional information was received from the manufacturer¿s representative (rep): the rep did not know whether an out of box failure was suspected with either ins and did not know the patient's current status and recommended follow-up with the hcp.No symptoms were reported and no further complications were reported or are anticipated.

Manufacturer Narrative

Correction: d11 concomitant product type (lead) was corrected: continuation of d11: product id 3889-28 lot# serial# (b)(4) impla nted: (b)(6) 2011 explanted: product type lead h6: device code c63114 no longer applies, instead: c62826 applies.Related ins s/n (b)(4) was submitted in reg.Report # # 3004209178-2019-07850 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.

Event Description

Additional information was received from the manufacturer¿s representative (rep): when asked what was meant by impedances were check ed and 3 of 4 electrodes were fine the rep responded: when testing impedance with the physician programmer, one electrode at all combinations showed a black line/invalid ???? responses.The rep believed, it was electrode 3 that showed c<(>&<)>3 ????, 0<(>&<)>3 ????, 1<(>&<)>3 ????, 2<(>&<)>3 ???? with a black line showing on it.The other pairings where electrode 3 wasn¿t involved showed normal impedance readings.No symptoms were reported and no further complications were reported or are anticipated.

• 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: 8531785
• MDR Text Key: 142500604
• Report Number: 3004209178-2019-07844
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: 04/19/2019; 04/22/2019; 05/09/2019
• Supplement Dates FDA Received: 04/22/2019; 04/23/2019; 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR