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

Model Number 3058

Device Problems Shipping Damage or Problem (1570); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331); Injury (2348); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot#: va1cpxe, implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead.Product id: 3889-28, lot#: va14dvf, implanted: (b)(6) 2016, explanted: (b)(6) 2017.Product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 17-nov-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from an attorney regarding a patient.It was reported that during their post-op period, their incontinence was worse, and they had more discomfort and pain when using the implantable neurostimulator (ins) as opposed to when the device was turned off at the lowest setting.The patient often had to shut the device off, or turn it to the lowest setting, because it was causing them pain.The patient experienced ongoing pain in the form of electrical shocks-pricks in their buttocks even on the device¿s lowest settings and they also suffered from right flank pain.It was noted that the post-op period was from (b)(6) 2017 to (b)(6) 2018.On or about (b)(6) 2018, the patient presented to their physician complaining that their malfunctioning ins was causing them a sensation when the device was on.The patient described it as ¿like a hot poker up their anus¿ and said that the device had not worked well since it was implanted on (b)(6) 2017.The patient sustained injuries from the device and was forced to undergo an additional and unnecessary surgery.The patient did not benefit from the device in controlling and/or treating their medical condition.As a result, the patient had suffered greatly, both mentally and physically.It was reported that the device was not properly manufactured or designed to prevent electrical currents and/or shock sensations, which would cause pain to the consumer.It was alleged that the medical device was in a defective condition and unreasonably dangerous when put to use, and that the defective condition existed when the product was sold and placed in the stream of commerce.The attorney stated that the medical device that was placed in the patient¿s body failed, leading to electrical shocks and current and otherwise not operating properly leading to severe physical injury.It was noted that the system was removed and replaced on (b)(6) 2018.No further complications were reported.Indication for use was gastrointestinal/pelvic floor.

• 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: 8397470
• MDR Text Key: 138096358
• Report Number: 3004209178-2019-04685
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2019

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: 07/14/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/06/2019
• Date Device Manufactured: 01/17/2017
• 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): Required Intervention