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

Model Number 3058

Device Problems Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

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

Event Date 09/02/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3889-28, lot# va0qqn2, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received regarding an implantable neurostimulator (ins) used for urinary dysfunction/sacral nerve stim as well as gastrointestinal/pelvic floor.Health care professional reported the patient¿s ins was removed but the lead was left implanted.It was reported that the cause for the removal was that ins wasn't functioning anymore.It was unknown if that meant the therapy wasn't working or if the ins quit working.It was reported that the ins was removed about 1.5 years ago.No further complications 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: 7316305
• MDR Text Key: 101591777
• Report Number: 3004209178-2018-04410
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2018

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: 04/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/06/2018
• Date Device Manufactured: 10/22/2014
• 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: 85 YR