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

Model Number 3058

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Urinary Retention (2119); Tingling (2171); Therapeutic Response, Decreased (2271); Electric Shock (2554); Alteration In Body Temperature (2682)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer implanted with a neurostimulator for gastrointestinal/pelvic floor.It was reported that since last wednesday (b)(6) 2020 the patient was getting shocked from the waist down.The patient said that their feet will get hot as well and when they cool down, they start to tingle.The patients healthcare professional recommended to turn the device off until monday.The patient decreased stimulation to 0.1v.Since the patient turned down stimulation, they had a return of symptoms.The patient was having ¿troubles emptying.¿ patient services reviewed information and possible programming changes.The patient was redirected to follow up with their healthcare provider to potentially schedule an appointment with a manufacture representative.There were no falls/trauma reported.No further complications were reported.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9861276
• MDR Text Key: 184314489
• Report Number: 3004209178-2020-05820
• 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: 04/01/2020

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: 05/28/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 04/01/2020
• Date Device Manufactured: 12/12/2019
• 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: 54 YR