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

Model Number 3889-28

Device Problems Bent (1059); Material Twisted/Bent (2981); Insufficient Information (3190)

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

Event Date 06/17/2018

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 manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation, fecal incontinence, and gastrointestinal/pelvic floor who reported that during the implant procedure the lead was bent.According to the caller the healthcare provider (hcp) inserted the lead into a foramen and noticed a bend in the lead at 0 <(>&<)> 1.The caller further mentioned that the physician opted to replace the lead.No patient symptoms were reported.There were no further complication reported or anticipated.

Manufacturer Narrative

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

Event Description

Follow-up with the manufacturer representative (rep) determined that the root cause of the lead being bent and not advancing could not be determined.There were no further complication reported or anticipated.

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

Event Description

Follow up information received from the manufacturer¿s representative reported that there was a damaged tip and the product would not advance.There were no further complications reported or anticipated.

Manufacturer Narrative

Below are the analysis findings and test results: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified the {x} electrode at the distal end of the lead was bent.If information is provided in the future, a supplemental report will be issued.

• 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: 7639082
• MDR Text Key: 112436738
• Report Number: 2649622-2018-10530
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00643169864436
• UDI-Public: 00643169864436
• 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,Followup
• Report Date: 11/01/2018

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: 05/01/2022
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1R0ZW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 07/24/2018; 08/08/2018; 10/27/2018; 10/31/2018
• Supplement Dates FDA Received: 07/27/2018; 10/02/2018; 10/30/2018; 11/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• 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: 70 YR