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

Model Number 3058

Device Problems Break (1069); Connection Problem (2900); Human-Device Interface Problem (2949)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that patient was having a pocket revision where they were moving the ins from the right to left side.It was noted that during the process they seemed to have 'stripped' the device and it was reviewed that if they backed the setscrew out too far, they would have to replace the ins.No further complications were reported.

Manufacturer Narrative

Analysis determined that the setscrew on the implantable neurostimulator (ins) was backed out beyond the point of being able to engage with the connector block.A lab functional test determined good stable output observed on #1, 2, 3.No output observed on #0 due to the setscrew being backed out too far.Setscrew could not be re-tightened on to the lead.Analysis determined there were no issues when pressing on the ins can and determined the telemetry was acceptable.If information is provided in the future, a supplemental report will be issued.

Event Description

No new information.

Manufacturer Narrative

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

Event Description

The manufacturing representative reported serial number of device.The cause of 'stripping the device' had not been determined.They tried to screw the lead into the battery multiple times and there were no clicks.The lead kept falling out of the battery, which was why a new battery was used.Patient weight was not available.They would return the old device to company.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7112666
• MDR Text Key: 94968686
• Report Number: 3007566237-2017-05165
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• 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