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

Model Number	3889-28
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Hematoma (1884); Therapeutic Effects, Unexpected (2099)
Date of Event	10/28/2016
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A healthcare professional (hcp) via a manufacturer representative reported a stimulated lead did not provide motor response during a procedure and felt there may be fault with the lead.When tested with the test stimulation cable, the lead did not provide a motor response.There was a large amount of blood surrounding the electrodes on the lead, which may have inhibited the stimulation of the lead.Troubleshooting was noted as foramen needle placed into left s4 foramen and testing with the test stimulation cable provided a motor response.The lead in question was then implanted into the left s4 foramen with no motor response when tested.Foramen needle inserted into right s4 foramen and testing with the test stimulation cable provided a motor response.Lead introducer/sheath dilator inserted into right s4 foramen and a large amount of blood came through the sheath once the dilator was removed.Dilator reinserted and lead introducer was slightly moved the minimize blood flow.Once blood flow had ceased the lead was inserted and there was no motor response when tested.No further actions were taken as a hematoma was forming and the surgeon removed the lead, and ceased procedure.The issue was noted as resolved.
Additional Manufacturer Narrative
Analysis of the lead, model 3889-28, serial/lot no.Unknown, found no anomaly.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): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 6112988
• Report Number: 3007566237-2016-04135
• Device Sequence Number: 10834705
• Product Code: EZW
• UDI-Device Identifier: 00613994601957
• UDI-Public: 00613994601957
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: 0211794366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Initial Date Received by Manufacturer: 10/28/2016
• Supplement Date Received by Manufacturer: Not provided; 12/22/2016
• Initial Report FDA Received Date: 11/18/2016
• Supplement Report FDA Received Date: 01/11/2017; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR