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

Model Number 3058

Device Problems Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 05/11/2010

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3889-33 lot# v394150 implanted: v(b)(6) 2010 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3889-33, serial/lot #: (b)(4), ubd: 19-jan-2014, udi#: (b)(4) 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.

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins) for the treatment of bladder issues.It was reported that patient inquired about laser therapy for their lower belly.Patient then mentioned that their ins doesn't work anymore and hasn't for years.Patient said the ins wasn't working correctly in the recovery room on implant day and it took them a year of trying to get it to work (to help with therapy issues).Patient said also on day of implant, they noticed their whole foot would do a complete curl, like a hand curling around a ball.Patient said it would take 10-15 seconds to open their foot and 10-15 seconds later their foot would curl again.Patient said their foot did this 24/7 and they eventually had to turn the ins off because their foot would cramp so bad and it was hard to walk.  they did one x-ray to figure out that the lead wire had an electrical short.Patient said the hcp told them the previous hcp must have tugged too hard and caused the short.Patient said the previous hcp pulled too tight and so the lead wasn't making the right connection all the time.Patient said the new hcp got their device to work correctly when they would sit down.Patient said they couldn't use the ins anymore because their foot didn't stop hurting and said they ended up having to get surgery on this foot.Patient said they were in pain for a year.Patient said they knew their issues (including therapy) were not due to the machine but due to the mishap of how it was put in.Patient mentioned the trial was perfection and they felt like they got their life back.Documented event and reviewed laser therapy guidelines with patient.Patient confirmed understanding.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: 16753183
• MDR Text Key: 313431074
• Report Number: 3004209178-2023-05128
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994287724
• UDI-Public: 00613994287724
• 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
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2011
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2023
• Date Device Manufactured: 03/04/2010
• 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: 46 YR
• Patient Sex: Female