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

Model Number 97800

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Fluid Discharge (2686)

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id 978b128 lot# va2suzc.Implanted: (b)(6) 2024.Explanted: (b)(6) 2024.Product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(6), ubd: 29-nov-2024, udi#: (b)(4).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.The rep reported that there was an ins in-pocket issue as the ins tilted.It was also reported that there was a discharge/wound weeping, an incision reopening or splitting open, and a health care professional noted a battery exposed at the incision site opening.During the case, a pocket was opened.Purulent drainage noted.This was cultured again.(prior to the explant, an open surgical site was cultured; days prior, no infection was noted.).Upon removal from the pocket, the provider noted that the battery was not connected to the lead.Both devices were explained in full.Hospital pathology requested a review of the device prior to returning to medtronic.Writer gave a convenient cell number to contact when they have completed there review.Culture was negative.Provider verbalized that she would like to open the pocket, flush with antibiotics and possibly replace the battery and use another tyrx pouch on monday (3/18/2024).The provider changed the plan of care intra-operatively.Total explant of lead and battery, wound culture obtained during surgical case.

Manufacturer Narrative

Continuation of d10: product id 978b128 implanted: (b)(6) 2024 explanted: (b)(6) 2024 product type lead medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the manufacturer representative (rep).The cause of the lead disconnecting from the ins was unknown.The provided did not indicate a reason at the time of the case.

• Brand Name: INTERSTIM X
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19050905
• MDR Text Key: 339487123
• Report Number: 3004209178-2024-08564
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 05/08/2024
• Date Device Manufactured: 10/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 120 KG