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

Model Number 3058

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Diarrhea (1811); Flatus (1865); Incontinence (1928); Complaint, Ill-Defined (2331); Abdominal Distention (2601); Test Result (2695)

Event Date 07/01/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported that the patient was tested for bacterial overgrowth and the test came back positive.The patient stated that they didn't treat it right away because they were trying to get them approved for a drug treatment (¿dibacstin¿?) which took 2 months.They were on the drug now but was still getting the symptoms and had ¿no control¿.The symptoms started about 2 months ago.There were no further complications reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer.The patient had called as they had received the letter sent to them and they provided the answers to the questions on the letter.In response to the inquiry of whether the issues had been resolved, the patient replied ¿no,¿ that they ¿d been ¿doing this every year and it has never been resolved.¿ the patient continued they temporarily resolve the problem, but they have never been able to solve the problem.The patient reported they had severe diarrhea, bloating and gas.In response to the inquiry for patient weight, the weight was unknown.The patient stated they didn¿t ¿know¿ that they reported ¿that.¿ patient services reviewed the information as reported in the original call and resulting letter.The patient stated that they had ¿no control of bowels.¿ the patient stated they didn¿t know if it was the bacterial overgrowth or what it was.There were no further complications reported.

• 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: 8787429
• MDR Text Key: 150957141
• Report Number: 3004209178-2019-13449
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/13/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 09/09/2019
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 74 YR