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

Model Number 3058

Device Problems Energy Output To Patient Tissue Incorrect (1209); Migration or Expulsion of Device (1395); Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Unstable (1667); Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Undesired Nerve Stimulation (1980); Swelling (2091); Discomfort (2330); Complaint, Ill-Defined (2331); Electric Shock (2554); Weight Changes (2607)

Event Date 01/18/2018

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 consumer 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 had fallen down a flight of stairs and since then their stimulator was acting kind of strange.The patient reported that their back where the implant was raised and felt like it was twisting, and it was swollen, and when they went to take a step they would get a shocking jolt.The patient stated they turned it off and even then, they were feeling the shock ping going down their leg, and it was just ¿like bruised¿.The patient noted that their healthcare provider could not see them until (b)(6), and they recommended that the patient call for a local representative or go to a local hospital to get it checked.The patient reported that prior to the fall everything was fine, but they were having worsening discomfort at the implant site and had turned it off completely, which did not resolve the issue.It was noted that the patient had started losing weight.The patient reported that at first, they thought maybe it was something small, but then notices it was constantly going on so they turned it off a few days before the report.The patient reported they thought maybe their body was sore from the fall because they were sensitive, but everything else had healed from the fall.The patient stated the device moved in their back and flipped sideways, and it felt like it a ¿cutting, slicing feeling¿ when it moved.The patient was redirected to their healthcare provider.No further complications were 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: 7317069
• MDR Text Key: 101860481
• Report Number: 3004209178-2018-04507
• 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: Other
• Type of Report: Initial
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2018
• Date Device Manufactured: 08/04/2016
• 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 Age: 28 YR