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

Model Number 3058

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Improper Device Output (2953)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins).It was reported that the patient stated the stim was electrocuting her back.Patient said it started a couple weeks ago and got extremely bad last week like friday or saturday.Patient said trying to get in the car took five minutes to just try and endure the pain and when she got in the car it didn't go away.Patient stated it was in her bad him and leg anyway and pain was coming from it.Patient stated she called the doctor¿s office.The first day she didn't hear back.The second day they said they are trying to get a hold of the rep.Patient stated she couldn't turn the device off, so she turned the stim down to 0.0 volts and then she didn't have the pain.Ins status was confirmed with patient programmer and it showed therapy was on.Patient turned stim off and had left it off.Patient said she had a colonoscopy, but they didn't remove anything.She said the issue started before the colonoscopy.Asked patient to see if they want to check the system or if they want to try turning it back on and slow increase the stim to see if it occured again.No further symptoms or complications reported/anticipated.

• 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: 7511850
• MDR Text Key: 108374551
• Report Number: 3004209178-2018-10841
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/14/2018

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: 07/14/2018
• 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: 05/10/2018
• Initial Date FDA Received: 05/14/2018
• Date Device Manufactured: 01/20/2017
• 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: 65 YR