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

Model Number 3058

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Vertigo (2134); Numbness (2415)

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor it was reported that the patient experienced vertigo and numbness as well as calf pain on (b)(6) 2018 stimulation was lowered and symptoms went away.Patient also started that it was not working like it used to before and that they had a loss of therapy.The cause of the issue was unknown at this time.No further complications were noted or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received and manufacturer representative reported that the it was a therapy issue and that the patient device was functioning properly.They further stated that multiple lead impedance checks have been performed and x-rays were reviewed by the md and the comment made by md is that lead appears to be in a good location.Patient feels stimulation at low outputs on all 4 programs.No further complications were noted or anticipated.

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: 7727222
• MDR Text Key: 115798534
• Report Number: 3004209178-2018-16842
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

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: 05/14/2019
• 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: 07/25/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 08/14/2018; 08/08/2018
• Supplement Dates FDA Received: 08/20/2018; 10/02/2018
• Date Device Manufactured: 11/14/2017
• 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: 71 YR