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

Model Number	3889-33
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturing representative (rep) regarding a patient implanted with a neurostimulator for urinary dysfunction/sacral stimulation, bowel dysfunction/sacral nerve stimulation, fecal incontinence, and gastrointestinal/pelvic floor.It was reported that during intra-operation there was lead steering difficulty.The rep stated that there was no product damaged caused or discovered during the procedure and no trouble shooting was conducted due to lack of access to the product.It was noted that the doctor was having trouble getting the lead into position and it wasn't picking anything up so the doctor wanted a different lead.The rep reported that the case was finished successfully with a different lead.There were no symptoms or further complications reported or anticipated.
Additional 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 or Problem Description
Additional information from the manufacture representative (rep) on (b)(6) reported the healthcare professional (hcp) was unable to steer the lead said the lead was defective, he wanted a new lead, a new lead was opened to and implanted.It was noted there was positioning difficulty.The rep stated there was no patient injury.Additional information from the patient on (b)(6) reported the lead was returned on (b)(6).There were no further complications that have been reported as a result of this event.
Additional Manufacturer Narrative
Analysis identified the electrode at the distal end of the lead was bent.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7157060
• Report Number: 2649622-2018-00003
• Device Sequence Number: 18867216
• Product Code: EZW
• UDI-Device Identifier: 00643169651128
• UDI-Public: 00643169651128
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2021
• Device Model Number: 3889-33
• Device Catalogue Number: 3889-33
• Device Lot Number: VA1J3JN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 01/07/2018; 02/22/2018
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 01/12/2018; 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR