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

Model Number 3058

Device Problems Break (1069); Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Response, Decreased (2271); Device Embedded In Tissue or Plaque (3165)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 388928, lot# unknown, implanted: (b)(6) 2017, 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 consumer was scheduled for a lead revision due to lead migration.While removing the lead, the lead fractured leaving the tines and electrodes in situ.A new lead was placed contralateral side.It was unknown if any factors led to the event.Troubleshooting was noted as intra-op testing of the lead before explanting and confirmation of lead position using ap and lateral images intra-op.Actions taken to resolve the issue were noted as surgical intervention to remove the lead.It was unknown if the issue was resolved at the time of the report.There were no further complications reported and/or anticipated.Additional information received reported the cause of the lead migration was not determined.It was noted that the lead migration was determined by x-ray.Symptoms were noted as the device stopped working.No further attempts to remove the lead fragments, lead electrodes abandoned, and a new lead was implanted.The cause was noted as the lead fragmented during very difficult attempt to remove, the lead had migrated downwards.The new implant was to be programmed on (b)(6) 2018.There were no further complications reported and/or anticipated.

Manufacturer Narrative

Product id: 388928, lot# va1d1tt, implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

• 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: 7329455
• MDR Text Key: 102064275
• Report Number: 3004209178-2018-04814
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

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: 06/14/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 05/08/2018
• Date Device Manufactured: 12/16/2016
• 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: 61 YR