MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number NEU_INTERSTIM_INS

Device Problems Migration or Expulsion of Device (1395); Positioning Problem (3009)

Patient Problems Pain (1994); Amnionitis (2217)

Event Date 04/02/2024

Event Type  Injury  

Manufacturer Narrative

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 an unknown source regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that had an ins implanted on (b)(6) subject persented to emergency department on (b)(6) 2024 with pain at ins site.Ed viewed and found nothing released subject home.The subject was seen on (b)(6) 2024, by dr.And they  identified a possible corner of the ins protruding under the skin. subject will undergo an ins revision, health care professional is  waiting for subject to be cleared for ins surgery.

Event Description

Additional information was received, from a manufacturer representative (rep).The rep reported, that the patient arrived at ed on (b)(6) 2024 with reports of pain, swelling and redness around the neurostimulator surgical site on the left buttock.Patient had lab work done and there is no sign of any infectious process.Her ct showed a few bits of air in the area of the device.Which, the ed provider believed were probably from the implantation itself.There is no sign of any infection or abscess formation.The orientation of the device was normal.Patient was started on antibiotics and has follow-up visit with dr.On (b)(6) 2024.At a visit with dr.On (b)(6) 2024, the device was found to be malformed.Surgery was scheduled for (b)(6) 2024 to reposition, but was canceled.And is tbd, due to an injury relating to the knee."it was stated, that inflammation, due to malposition of ins.

Manufacturer Narrative

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.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19105833
• MDR Text Key: 340227904
• Report Number: 2182207-2024-02301
• Device Sequence Number: 1
• Product Code: EZW
• 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: Study,Health Professional
• 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: NEU_INTERSTIM_INS
• Device Catalogue Number: NEU_INTERSTIM_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/08/2024
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 129 KG