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

Model Number	3889-28
Medical Device Problem Codes	Break (1069); Device Contamination with Chemical or Other Material (2944); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2017
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 the consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that implant procedure started with no issue.It was noted that the physician did not achieve the most ideal placement of the lead at implant, so they removed the lead from the introducer to attempt to re-insert the lead but noticed what they thought there was a defect in the lead which allowed blood to seep into the lead.The physician attempted to clean the lead to confirm the blood had seeped into the inner workings of the lead.It did appear the blood had compromised the lead event after cleaning it.The physician felt it best to use a new lead for the fear that it would cause issues for the patient and lessen the possibility of successful therapy.No factors were identified that may have caused the lead defect as it was noted the physician had done many implants with this device type with no issues.The physician did not handle the lead inappropriately or attempt anything out of the norm of the procedure.A new lead was then used and was placed without issue.The impedance check was reported as normal after the new lead placement.The issue was reported as resolved at the time of report.There were no further complications reported or anticipated.
Additional Manufacturer Narrative
Device returned, analysis not yet complete.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the lead (serial # (b)(4)) was completed and found there was an inadequate adhesive in the electrode slot.Also, electrical testing was performed and no electrical shorts were identified between circuits.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Analysis result was completed.

• 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: 6995079
• Report Number: 2649622-2017-12833
• Device Sequence Number: 1005735
• Product Code: EZW
• UDI-Device Identifier: 00643169651111
• UDI-Public: 00643169651111
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1DWWK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 11/06/2017; 11/21/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 11/13/2017; 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR