MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3889-33

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_tunnelingtool, product type accessory.(b)(4).

Event Description

A manufacturer representative reported that a healthcare provider ended up "going through two tunneling tools" during the patient's stage one implant procedure.It was noted that the patient was a large person weighing 126 kilograms and when they tried to tunnel contralaterally both straws of the tunneling tools had "crinkl[ed] up like an accordion." it was stated that the healthcare provider had to push really hard to tunnel.They had tried to trim the edges but then it wasn't long enough to reach the pocket site.The tunneling tool made it to the pocket, was tunneled another seven inches to do a test, and the straw "accordioned" on itself in the tunnel between the pocket and the other seven inches.The damage was the same to both straws.Another lead kit had been opened to get a third tunneling tool, which resolved the issue.Nothing was done differently with the third tunneling tool, they thought they just got through far enough with the first two and the last one just finished up without any damage.It was added that there was no trouble inserting the lead, there weren't any issues screwing on the tip of the tunneling tool, and there was no damage to either straw prior to tunneling.No symptoms were reported.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5145664
• MDR Text Key: 28085893
• Report Number: 3007566237-2015-02907
• Device Sequence Number: 1
• Product Code: EZW
• 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
• Reporter Occupation: Other
• Report Date: 08/27/2015

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 Model Number: 3889-33
• Device Catalogue Number: 3889-33
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2015
• 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