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

Model Number 3058

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3889-28, lot# va0q4mk, implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: lead.The event date is approximate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a consumer who was implanted with a neurostimulator to manage urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.It was reported that the patient had their device removed on (b)(6) 2017.During the explant, a three inch portion of the lead broke off and remains in the patient's sacral area.This was seen on an x-ray.The hcp asked for mri guidelines, as the patient was getting a pelvic mri for back pain that started 2-6 months ago.No further complications were anticipated/reported.

Manufacturer Narrative

Correction was made to add a new patient code of (b)(4).Also device code (b)(4) was added to reflect accurate event reporting, and the device code in the initial regulatory report of (b)(4) was removed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from healthcare professional (hcp) reporting that the current status of the ins was unknown as it was kept by the surgery center.And that patient was not seen by the hcp for back pain so there was no cause noted.Lastly there were no actions taken as back pain was not treated by hcp.No further complications were reported.

Manufacturer Narrative

(b)(4).Which pertains to product id: 3889-28, lot# va0q4mk, product type: lead.This device is included in the medical device correction, "unretrieved device fragments models 3093 and 3889 interstim tined lea ds", educational brief/physician communication ( (b)(6)2010).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: 7153078
• MDR Text Key: 96001636
• Report Number: 3004209178-2017-26767
• 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: health professional
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2018

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: 07/14/2016
• 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: 12/27/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 12/27/2017; 01/09/2018
• Supplement Dates FDA Received: 01/03/2018; 01/09/2018
• Date Device Manufactured: 01/16/2015
• 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: 72 YR