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

Model Number 97800

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Electric Shock (2554); Constipation (3274); Insufficient Information (4580)

Event Date 04/09/2024

Event Type  malfunction  

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 a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that they were incredibly constipated the first few days after implant.Patient stated they were taking a lot of fiber pills and stool softeners and that had sort of gotten better.Patient confirmed they did not feel a constant fluttering sensation.Patient reported feeling a shocking sensation near the hip joint at least once a day since implant.Patient said they could feel the "outline of the implant".When agent asked patient to place the communicator over the implant to review device education, patient expressed feeling like someone jabbed them with an ice pick and it caused a sharp pain in their hip.Patient stated the first time they felt the pain in the hip, they called the manufacturer representative (rep) who suggested to turn the stimulation down but the patient preferred not to do it.Patient reported they had not had any shocking episodes yesterday (b)(6) 2024) or today.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.At the end of the call, patient expressed never being constipated.

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

Additional information was received from the patient.They stated they spoke with their manufacturer representative (rep) and will be following their advice about how to continue doing changes to their therapy.

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

Additional information was received from the patient.The patient repeated that program 1 was giving them a severe shock in their hip.Patient said they spoke with a rep who moved them to program 2 and the shocking sensation was no longer as severe as it was, but was still there occasionally.Patient was traveling and did not have the external devices with them at the time of the call.The patient was redirected to their healthcare provider to further address the issue.

• 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: 19153329
• MDR Text Key: 341385935
• Report Number: 3004209178-2024-09498
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2024

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
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 04/29/2024; 05/24/2024
• Supplement Dates FDA Received: 05/16/2024; 05/28/2024
• Date Device Manufactured: 02/12/2024
• 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 Age: 69 YR
• Patient Sex: Female