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); Unstable (1667); Positioning Problem (3009)

Patient Problems Emotional Changes (1831); Pain (1994); Swelling (2091); Discomfort (2330); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported the patient stated she was having problems since she had her device replaced.The patient was transferred to patient services.The patient reported her ins was not in the pocket and the patient kept telling her healthcare professional (hcp) it felt a knot or something and they thought it was tissue or swelling and since the implant the patient felt like they were getting tased inside of her vagina like an electrical shock.The patient noted they turned it down like a half way, but she felt strong shocks that bring her to tears and made her body jump.The patient noted they had been making adjustments to the way it flows, but it had not "resolve" the issue.The patient stated kept telling them she could feel the ridges of the top of the battery and pressure on and off.The patient noted they were supposed to undergo surgery to take the battery out and put it down deeper in the pocket.The patient hcp stated sometimes this could happen when they healed.The patient stated the ins was still under the skin, but tilted and the patient could feel the ridges where the wires were located.The patient stated they could feel pain from the battery case all down her right leg and it was swelling.The patient noted they were taking pain pills.The patient stated when they bent over there was like a pull underneath the pocket where the battery is.It was noted the patient was scheduled for a revision on (b)(6) 2018.There were no further complications that have been reported as a result of this event.

• 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: 8016057
• MDR Text Key: 125364882
• Report Number: 3004209178-2018-24143
• 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
• Report Date: 10/29/2018

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: 06/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 10/29/2018
• Date Device Manufactured: 12/20/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 54 YR