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

Model Number 3058

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Incontinence (1928); Pain (1994); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

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 patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.The patient reported that the problems started two weeks after implant (implant (b)(6) 2016).The patient reported pain, felt like hand in a light socket that lasted several seconds enough to cause patient to yell out and just quit.The patient reported that it felt like someone was throwing knives at them.The patient reported that at the get go they felt great and symptoms were great.The patient reported that they went back to their healthcare provider (hcp) on (b)(6) 2016 and the hcp did an adjustment from 2 something to 1 something.The patient reported that they were leaking, sneezing, coughing and couldn¿t make it to the bathroom so the patient thought it was turned down too much and pain started.The patient reported that it didn¿t matter where sitting, lying; the pain hits the patient and jarred out of skin.The patient reported that they saw their hcp on the day prior to the report and he adjusted and the symptoms were gone and better but the pain was still there and caused the patient to wake up at 4am.The patient reported that it wasn¿t a constant pain and it just hit out of the clear blue.The patient reported that they had an appointment on (b)(6) 2016 and have the hcp look over it.

Manufacturer Narrative

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

Additional information was received.It was reported that the patient was told by their healthcare provider to wait after adjusting the stimulation.The patient was later told of turn off the stimulation.The patient was still experiencing pain at the site of implant.

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: 6214409
• MDR Text Key: 63625062
• Report Number: 3004209178-2016-27454
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2017

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: 02/28/2018
• 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: 12/08/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided; 01/03/2017
• Supplement Dates FDA Received: 01/11/2017; 09/28/2017
• Date Device Manufactured: 08/31/2016
• 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