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

Model Number 3058

Device Problems Break (1069); High impedance (1291); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problems Electric Shock (2554); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 388928, lot# 0209608489, implanted: (b)(6) 2015, explanted: (b)(6)2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from a healthcare professional (hcp) via a manufacturer representative reported a lead fracture.A consumer fell while running and reported that when he got home, he experienced jolting stimulation that cut in and out with position change.An impedance test was run, and all electrodes were > 4000 ohms.The lead and implantable neurostimulator (ins) were both replaced.It was noted that the ins was not related to the event, but was replaced as the hcp did not want to replace a flat battery in the next 12 months.Troubleshooting noted that a battery test was done.During explant of the lead, the tip of the electrode broke off, and it was noted that it may have already been broken.The issue was resolved.There were no further complications reported and/or anticipated.

Manufacturer Narrative

Analysis of the lead, model 3889-28, found all conductors were broken in the body of the lead; 23.2 cm from the proximal end of the lead.During visual analysis of the lead, it was noted the distal end was not returned.Analysis identified markings on the outer insulation of the lead which is consistent with markings from the use of a tool.The ins output was tested through the returned ins to broken lead.Good stable output was observed on all electrode pairs the ins had when it was received.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported the tip was left in as too difficult to remove and there were no plans to retrieve it.

• 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: 7288054
• MDR Text Key: 100643039
• Report Number: 3004209178-2018-03740
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2018

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: 11/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 03/07/2018
• Supplement Dates FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2015
• 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