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

Model Number 3058

Device Problems Break (1069); Shipping Damage or Problem (1570); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 01-may-2022, udi #: (b)(4), implanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare professional (hcp), via the manufacturer¿s representative, regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient had the lead and ins replaced.It was noted that the doctor tried to remove the old lead but it broke off.It was unknown if there were any environmental/external/patient factors that may have led to the issue.As diagnostics and actions taken performed to resolve the issue, multiple reprogrammings were performed.At the time, the doctor believed the risk was to high to go digging after the fragment.The patient then went to another doctor and had a new lead and ins placed.The other doctor removed the old fragment of the lead that the previous physician could not remove.It was unknown if the issue was resolved.The patient status was noted as ¿alive ¿ no injury¿.There were no further complications reported or anticipated.

Manufacturer Narrative

Product id: 3889-28, lot# va14dvf, implanted: (b)(6) 2016, explanted: (b)(6) 2017, product type: lead.Correction: notified date should be 2019-feb-12.(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 there were two leads located within the patient¿s body, their existing lead and the replacement lead.The patient¿s previous/existing lead, which was implanted on (b)(6) 2016, was left in their body and eventually removed on (b)(6) 2018.It was further reported that the patient¿s physician attempted to remove the old lead when implanting their replacement lead on (b)(6) 2017, but the lead broke off.At the time, the physician believed the risk was too high to dig after it.As a result, the patient had suffered greatly, both mentally and physically.It was reported that the patient sustained injuries as a result of the lead fragment being left in their body and was forced to undergo an additional and unnecessary surgery.It was reported that the device was not properly manufactured or designed to prevent injury to the consumer.It was alleged that the medical devices were in a defective condition and unreasonably dangerous when put to use, and that the defective condition existed when the products were sold and placed in the stream of commerce.The devices failed and did not operate properly, leading to severe physical injury.It was unknown if there were any environmental or external factors that may have led or contributed to the issue.The manufacturer representative further reported that multiple reprogramming sessions were performed, but it was unknown if the issue was resolved.It was noted that the patient saw a different physician who was able to remove the old fragment of the lead that the previous physician could not remove.No further complications were reported or anticipated.Indications for use were gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stimulation.

• 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: 8367527
• MDR Text Key: 137056525
• Report Number: 3004209178-2019-03916
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 05/28/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 03/06/2019
• Date Device Manufactured: 12/02/2015
• 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 Weight: 58