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

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Paralysis (1997); Weakness (2145); Distress (2329); Electric Shock (2554)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product type: lead.Product id: 3889-33, lot#: va1ggyh , implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: lead.Other relevant device(s) are: product id: 3889-33, serial/lot #: (b)(4), ubd: 26-apr-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient re-reported that they got thrown off a trailer and the implant broke.They stated they had the ins replaced on (b)(6) 2017 due to this and stated they didn't think their healthcare provider replaced the leads at that time.They stated they thought this because it wasn't any different after.They clarified that the implant moved over into their spine and was paralyzing their legs and they needed therapy.They stated that if they would have taken the old one out the first time their legs would have straightened out.They confirmed this was a continuation of a previously reported event and that this first started on (b)(6) 2017.They re-reported that a couple of weeks later the stimulator where they had fallen broke and it shocked them like a taser going between their legs.They stated they went to the hospital due to this and stated they called pennsylvania to shut it off because they didn't know how to.They stated that then their healthcare provider came back from vacation and they decided to try again.The patient stated that if their healthcare provider would have taken the old wiring their legs wouldn't have been paralyzed because it moved into their spine.They stated when they went back and told their healthcare provider to turn off the stimulation and the patient stated they could feel a difference when the stimulation was shut off.They stated their neurologist told them to have the entire system removed due to the events previously reported and noted above.They stated they had the ins and leads removed about 3 weeks prior and stated that since then they could stand up and walk and their legs were working, but their body was very weak and stressed because this had been a 3 year thing.They confirmed they did not have any leads or ins implanted at the time of the report.It was noted that the patient was difficult to follow throughout explaining the timeline of events.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9375994
• MDR Text Key: 168820409
• Report Number: 3004209178-2019-22618
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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: 11/26/2019

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: 04/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/26/2019
• Date Device Manufactured: 10/22/2017
• 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): Other; Required Intervention
• Patient Age: 73 YR