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

Model Number	3889-33
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product id: neu_stylet_acc, serial# unknown, product type: accessory.Product id: 3058, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.Product id: 3058, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.
Event or Problem Description
A healthcare professional (hcp) reported via a manufacturer representative (rep) that the lead came apart at the proximal end, the r ep noted it shredded from the plastic covering.The rep stated there were no environmental, external, or patient factors that may have led or contributed to the issue that they observed.The rep noted the lead was replaced with a full functioning lead and the issue was resolved at the time of the report.The patient is implanted for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.
Additional Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id: neu_stylet_acc, lot# serial# unknown, product type: accessory.Product id: 3058, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.Product id: 3058, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.\tined lead (va1asts) was returned and analysis found stim lead body/ outer insulation/ separated at butt joint, proximal end.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 6264695
• Report Number: 2649622-2017-00035
• Device Sequence Number: 970356
• Product Code: EZW
• UDI-Device Identifier: 00643169651128
• UDI-Public: 00643169651128
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2017

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: 09/21/2020
• Device Model Number: 3889-33
• Device Catalogue Number: 3889-33
• Device Lot Number: VA1ASTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided; 02/16/2017
• Initial Report FDA Received Date: 01/19/2017
• Supplement Report FDA Received Date: 03/01/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR