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

Model Number 3058

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Irritation (1941); Pain (1994); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Constipation (3274)

Event Date 05/19/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot#: va1c4m4, implanted: (b)(6) 2016, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 31-oct-2020, udi#: (b)(4).(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins) for gastrointestinal/pelvic floor.Caller was implanted for urinary tract infections (uti) and is in excruciating pain like something is poking them.They noted that they had to sit on a heating pad from last night up until calling the manufacturing company today.Caller inquired about the explant procedure, if the manufacturing company was in/out of network; information was reviewed.Patient said they had an x-ray taken which revealed the lead migrated, but the healthcare provider (hcp) told them it might move back on its own.They added that they take ibuprofen through the day.The patient also said the device is close to the skin because they lost weight.They noted that they will be going to the healthcare provider (hcp) on (b)(6) 2019 for an appointment.As a result of what was reported, the patient was redirected to the hcp.Patient also said they met with a manufacture representative (rep) who turned the electrodes off; they felt better afterwards.Patient also reported an incident where they were constipated so they took a laxative, but was up all night.They felt like they had a colonoscopy prep and that they have a "ball underneath [them]".No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product id 3889-28, lot# va1c4m4, implanted: (b)(6) 2016, explanted: (b)(6) 2019, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer indicating that the patient had the implant put in to help with utis, but something was wrong, and they could feel the ins when they laid down.The patient reported they had their device removed two weeks ago to resolve the system migration and since having it removed, they were having pain.The patient asked how far the healthcare provider have to place ins or remove them.The patient stated their healthcare provider seemed annoyed that they were having pain and they didn¿t know whey they were having pain on the incision area.The patient noted they were putting ice, trying to take care of the pain but it hurt, and they had a cat scan done the day before and nothing showed up except gall stones and that was not causing the pain.The patient also reported they had called their previous healthcare provider as well as their current one to figure out what to do next.The patient mentioned they weren¿t sure if the healthcare provider removed the wire, but the cat scan didn¿t show anything, so they thought everything was removed, but they weren¿t sure.The patient was redirected to their healthcare provider.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Follow up information received from the patient reported that their implanted device removed on (b)(6) 2019.The patient that the doctor never gave them the explanted implanted device back.They stated that ¿i never thought it should be after being taking out at my request¿.The patient also stated that they felt the ¿wire was irritating¿.The mentioned that they had instances of pain and their doctor was not sensitive to their pain.The patient asked to be put to sleep when they went in to take the device out.In addition, the patient stated that it ¿has affected my bowel movement and was resolving¿.[note: other information provided by the patient was illegible].There were no further complications reported or anticipated.

• 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: 8968984
• MDR Text Key: 156987593
• Report Number: 3004209178-2019-17097
• 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,Followup,Followup
• Report Date: 11/04/2019

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: 04/28/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 09/23/2019; 10/08/2019
• Supplement Dates FDA Received: 10/08/2019; 11/04/2019
• Date Device Manufactured: 11/10/2016
• 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: 76 YR
• Patient Weight: 62