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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problems Incontinence (1928); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 3889-28, lot# va05yv3, implanted: (b)(6) 2013, product type: lead.The codes listed apply to both lead and ins.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.

Event Description

Information was received from a consumer via a manufacturer¿s representative regarding a patient with an implanted neurostimulator ( ins) for gastrointestinal /pelvic floor therapy.It was reported that the patient had been leaking for a while and wore pads.When their battery and lead were replaced it was discovered that the lead wire was "misplaced", meaning it was totally out of place, which is the reason it was not working and the patient wasn¿t getting the stimulation she needed.The healthcare professional (hcp) discovered the problem with the lead during a fluoroscopy and said the lead was pointing in a totally opposite direction than it should be for the nerve to be affected.Caller states the hcp said the lead was not broken but just out of place but the doctor opted to put in a new lead and ins.No further complications were reported or are anticipated.

• 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: 7152341
• MDR Text Key: 96003332
• Report Number: 3004209178-2017-26759
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2017

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: 07/14/2014
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2017
• Initial Date FDA Received: 12/28/2017
• Date Device Manufactured: 01/22/2013
• 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