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

Model Number 3058

Device Problems Premature Discharge of Battery (1057); High impedance (1291); Low Battery (2584); Battery Problem (2885); Impedance Problem (2950); Insufficient Information (3190)

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

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

Product id: 3889-33, lot# va16jhsv01, implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 3889-33, serial/lot #: va16jhsv01, ubd: (b)(6) 2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient with an implantable neurostimulator (ins) who reported that the patient's lead and battery were checked and the leads were found to have impedances on all electrodes and the battery was low with limited time left on it.The patient's battery and leads were replaced.The issue was reported as resolved at the time of this report and no patient symptoms were reported.There were no further complication reported or anticipated.

Manufacturer Narrative

Product id 3889-33 lot# va16jhsv01 implanted: (b)(6)2017 explanted: (b)(6)2018.Product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the hcp indicated that the ins was non-functioning.The device was explanted and returned for analysis.There were no further complication reported or anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Due to indrf harmonization, any previously submitted device, method, result, and conclusions codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Follow-up with the manufacturer representative (rep) determined that all impedances were high and over 4000 ohms and the cause of the device being non-functioning was the impedances.Additionally, the patient's battery depletion was considered abnormal depletion and the unit was replaced on (b)(6) 2017.

Manufacturer Narrative

H3: sis information -- 2018-07-25 12:23:34 cst pli# 10 product id# 3889-33 below is unedited, system generated text based on the analysis finding code(s) and test results.Analysis identified that the {x} conductor(s) was/were crushed in the body of the lead; however, electrical testing determined that continuity was complete and there were no electrical shorts between the circuits.Due to the reported complaint, an impedance test was performed in 0.9% saline solution and good impedances were observed using an n'vision clinician programmer.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Analysis identified markings on the outer insulation of the lead which is consistent with markings from the use of a tool analysis information -- 2018-07-25 12:22:22 cst pli# 20 product id# 3058 below is unedited, system generated text based on the analysis finding code(s) and test results.Analysis observed no output or telemetry on the implantable neurostimulator (ins) and determined normal battery depletion.A lab functional test determined that no output was observed on any electrode pair.{no output} analysis determined the telemetry was acceptable.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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: 7637732
• MDR Text Key: 112317833
• Report Number: 3004209178-2018-14309
• 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,Followup
• Report Date: 10/05/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 06/22/2018; 07/13/2018; 07/31/2018; 07/31/2018; 08/08/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 06/29/2018; 07/13/2018; 08/01/2018; 08/01/2018; 10/04/2018; 10/04/2018; 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR