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

Model Number 3058

Device Problems Shelf Life Exceeded (1567); Malposition of Device (2616)

Patient Problems Unspecified Infection (1930); Skin Discoloration (2074); Pressure Sores (2326)

Event Date 06/28/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 309333, lot# 0205954316, implanted: (b)(6) 2016, product type: lead.Product id: 309333, lot# 0205954316, implanted: (b)(6) 2016, product type: lead.(b)(4).

Event Description

A manufacturing representative (rep) reported on behalf of a healthcare provider that the skin around the stimulator was darkened.The implantable neurostimulator (ins) location was inappropriate and skin ulcers lead to infection.There were no problems with the stimulator loop, the patient symptoms were still well controlled; only skin problems.A debridement and skin grafting were performed and they moved the stimulator.It was noted that the issue was resolved at the time of the report.No further complications were reported/anticipated.

Manufacturer Narrative

Note that section d information references the main component of the system and other applicable components are: product id 309333 lot# 0205954316 serial# implanted: (b)(6) 2016 explanted: product type lead: based on additional information received fdd (b)(4) no longer applies to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the representative clarified the implant date of the lead to be (b)(6) 2016.It was noted that the physician considered the inappropriate location as the cause and the infection was resolved.

• 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: 6691045
• MDR Text Key: 79232536
• Report Number: 3004209178-2017-14347
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

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: 07/14/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 08/08/2017
• Supplement Dates FDA Received: 08/15/2017
• Date Device Manufactured: 01/20/2016
• 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: 65 YR