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

Model Number 3058

Device Problems Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant product(s): product id: 309328, lot# 0205841884, implanted: (b)(6) 2012, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from the healthcare professional (hcp) via a manufacturer representative (rep) for a clinical study reported that the electrode distal end was not removable at the time of the explant, without patient symptoms.Factors that may have led or contributed to the issue remain unknown.No diagnostics/troubleshooting was performed and no additional actions were planned/taken.The issue was not resolved, however a surgical intervention did occur.Relevant medical history includes urge incontinence and pollakiuria.No further complications were reported/anticipated.

Manufacturer Narrative

Product id (b)(4) lot# 0205841884 implanted: (b)(4) 2012 explanted: (b)(4) 2015 product type lead if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that the device deficiency was not related to the procedure and not related to any adverse event.The cause of the event remains unknown and the status of the device remains unknown.No further complications were reported/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: 7148196
• MDR Text Key: 95834361
• Report Number: 3004209178-2017-26674
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/23/2018

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: 06/28/2016
• 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: 12/21/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 12/28/2017
• Supplement Dates FDA Received: 01/23/2018
• Date Device Manufactured: 01/08/2015
• 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 Age: 64 YR
• Patient Weight: 64