MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3023

Device Problems Break (1069); Degraded (1153); Difficult to Remove (1528); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917); Impedance Problem (2950); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Hematoma (1884); Nausea (1970); Scar Tissue (2060); Urinary Retention (2119); Electric Shock (2554); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3886, lot# l97836, implanted: (b)(6) 2001, explanted: (b)(6) 2018, product type: lead.Product id: 3095-10, serial# (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2018, product type: extension.Information references the main component of the system.Other relevant device(s) are: product id: 3886, serial/lot #: (b)(4), ubd: (b)(6) 2005, udi#: (b)(4); product id: 3095-10, serial/lot #: (b)(4), ubd: (b)(6) 2012, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding their implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation.It was reported that patient's ins, extension, and lead was surgically removed and replaced the friday before the report.It was noted that the doctor could not detect the leads in (b)(6), so they scheduled the patient for system replacement.During the surgery, the extension and lead were found in pieces and looked like a corroded battery with white stuff.The doctor had difficulty removing the lead and extension due to these issues, and was able to remove most of the white substance but not all.No further complications were reported.

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

Additional information received from the patient stated her body rejected the lead and had replacement.Patient said the white stuff she thought was battery acid was her body rejecting the lead.Patient said after the removed the device they implanted the system on the left side.Patient said she has a huge lump or hematoma still and they could feel it from where they were digging around.She said, she has a whole bunch of scars.Patient said she was systematic and having shocks with the old device.Patient said he replaced the ins in 2009 due to normal battery depletion but didn't replace the leads, and maybe that is why her body rejected the lead.Patient said after the removed this device they implanted the system on the left side.Patient said she has a huge lump or hematoma still and they could feel it from where they were digging around.She said, she has a whole bunch of scars.When the doctor ran impedances he didn't get any numbers back.Patient said she felt like the device wasn't working right.The lead was not replaced, and maybe that is why her body rejected the lead.The surgery was 3 hours long instead of an hour and a half.Patient said she got a little nauseous that time.Patient said they didn't put in a catheter probably because they didn't' think the surgery was going to last that long.Patient had an extended bladder and had to go home for the weekend with a cath.Patient said she also had a reaction to the antibiotic and she broke out in a rash.No further patient complications are anticipated or expected as a result of this event.

Event Description

Additional information was received from the patient.They reported that they left the lead in because they didn't want to traumatize the area any further.

Manufacturer Narrative

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.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7723798
• MDR Text Key: 115187232
• Report Number: 3004209178-2018-16753
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994287731
• UDI-Public: 00613994287731
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/25/2023

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: 11/28/2010
• Device Model Number: 3023
• Device Catalogue Number: 3023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 02/06/2020; 08/04/2023
• Supplement Dates FDA Received: 10/04/2018; 02/21/2020; 08/25/2023
• Date Device Manufactured: 06/02/2009
• 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: 64 YR
• Patient Sex: Female