MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3093-28, lot# v741591, implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: lead.Information references the main component of the system.Other relevant device(s) are: product id: 3093-28, serial/lot #: (b)(4), ubd: (b)(6) 2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal floor.It was reported by a healthcare professional, possibly an mri tech on (b)(6) 2018 that the patient had a lead tip left at their sacrum, but the rest of the implant had been removed.Caller didn't know when it was removed and was calling because the patient needed an mri.No patient symptoms were reported.On (b)(6) 2018 the device - managing healthcare professional reported the cause of the lead tip remaining in the patient after explant was that the lead fragmented at the time of product removal.No further complications were reported or anticipated.

Manufacturer Narrative

The date for the first supplemental sent should have been (b)(6)2018 product id (b)(4) lot# v741591 implanted: (b)(6)2012 explanted: (b)(6)2015 product type lead.Product id: (b)(4).Serial/lot (b)(4), ubd: (b)(6)2015, (b)(4) information references the main component of the system and other applicable components are: applies to the lead.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction was made: adverse event was added: product id (b)(4) lot# (b)(4) serial# implanted: (b)(6) 2012 explanted: (b)(4) 2015 product type lead information references the main component of the system.Other relevant device(s) are: product id: (b)(4), serial/lot #: (b)(4) , ubd: (b)(4) 2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional: the patient was not seen in their office since 2016.No further complications were reported or are anticipated.

Manufacturer Narrative

(b)(4).Continuation of concomitant products: product id 3093-28; lot# v741591; implanted: (b)(6) 2012; explanted: (b)(6) 2015; product type: lead.Other relevant device(s) are: product id: 3093-28, serial/lot #: (b)(4), ubd: 02-jun-2015, udi#: (b)(4).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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7638149
• MDR Text Key: 112457667
• Report Number: 3004209178-2018-14333
• Device Sequence Number: 1
• Product Code: EZW
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2013
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2018
• Date Device Manufactured: 01/09/2012
• 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 Weight: 68