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

Model Number 3058

Device Problems Contamination (1120); Device Operates Differently Than Expected (2913)

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

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id 3889-28, lot # va1bm9f, product type lead.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Event Description

Information was received from a company representative regarding a patient who was implanted with a neurostimulator.It was reported that there was blood inside the sheath of the lead upon removing it from the lead intruder.They repositioned the lead and retested with no response.A new lead was opened and retested with success.The issue was resolved at time of the report.Patient status was noted as alive, no injury.The non-implanted lead would be returned to the manufacturer.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 3889-28, lot# va1bm9f, product type: lead.Product id: neu_stylet_acc, serial# unknown, product type: accessory.Analysis of lead (lot #va1bm9f) found that distal end of stim lead body revealed that inadequate adhesive in the slot.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.

Manufacturer Narrative

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6146043
• MDR Text Key: 61493300
• Report Number: 3004209178-2016-25179
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided; 01/11/2017
• Supplement Dates FDA Received: 01/12/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2016
• 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 Age: 75 YR