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

Model Number 388928

Device Problems Bent (1059); Break (1069)

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

Event Date 04/25/2017

Event Type  malfunction  

Event Description

A healthcare professional (hcp) via a manufacturer representative reported a defective electrode that occurred during pre-op.It was noted that the electrode was not implanted in the consumer.No symptoms were reported.There were no further complications reported and/or anticipated.

Manufacturer Narrative

Analysis of the lead, model 388928, found lead body outer insulation separated at a butt joint/proximal end.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Analysis observed the distal end of the lead was stretched.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the representative clarified that the electrode had a deviation at the tip.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6530045
• MDR Text Key: 74040102
• Report Number: 2649622-2017-04884
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2020
• Device Model Number: 388928
• Device Catalogue Number: 388928
• Device Lot Number: 0212303939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: Not provided; 07/11/2017; 07/11/2017
• Supplement Dates FDA Received: 06/19/2017; 07/17/2017; 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2016
• 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