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

Model Number	3889-28
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received by a manufacture representative (rep) via a healthcare provider (hcp) regarding an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.While intra-op, a lead was implanted during a stage 2 implant.During intra-op testing, impedance testing was greater than 4000 ohms on all combinations except for 1.Amplitude was adjusted twice to 1.5v then 2.0v as well as a pulse width to 270 which still impeded out.The hcp decided to remove and replace the lead.The lead will be returned to be analyzed.No patient symptoms and no further complications have been reported as a result of this event.
Event or Problem Description
No new information was reported.Device received for analysis.
Additional Manufacturer Narrative
Analysis of the lead model 3889-28, lot # va1gdqt, showed conductor 0, 1, and 2 were broken 2.6 cm from the proximal end (in the body of the lead) within 10 cm of the area of the connector.The conductors were stretched and the conductor coils were crushed.The outer insulation was pinched and there was suspected body fluids observed in the lead.No shorts were seen between circuits and open circuits were seen on 0, 1, and 2.The continuity was acceptable.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
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
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.

• 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: 6562677
• Report Number: 2649622-2017-04923
• Device Sequence Number: 16176353
• Product Code: EZW
• UDI-Device Identifier: 00643169651111
• UDI-Public: 00643169651111
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/13/2017

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: 04/20/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1GDQT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: Not provided; 06/20/2017; 06/20/2017; 06/20/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 06/01/2017; 07/13/2017; 10/04/2017; 10/04/2017
• 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: 35 YR