MAUDE Adverse Event Report: NEURO - VILLALBA; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	3708640
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional (hcp) via the manufacturer representative (rep) reported that multiple impedance tests resulted in high impedances on contact 2 during implant/"normal installation" on date notified.Impedances were tested once the extension was connected to the lead and implantable pulse generator (ipg).The extension was explanted/replaced as a result, resolving the issue.The patient's indication for implant is unknown.
Additional Manufacturer Narrative
Analysis of the extension 3708640 dbs no tunneling tool s/n (b)(4) confirmed the allegation.It was found that the stimulation extension body conductor was broken 2.8cm from the distal end.Circuits 0, 1, 2, and 3 were also low showing impedances ranging from 8.6 to 9.8 ohms.
Additional Manufacturer Narrative
(b)(4).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.

• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• MDR Report Key: 6375956
• Report Number: 6000153-2017-00014
• Device Sequence Number: 31130
• Product Code: EZW
• UDI-Device Identifier: 00613994749109
• UDI-Public: 00613994749109
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/28/2017

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 Expiration Date: 12/08/2018
• Device Model Number: 3708640
• Device Catalogue Number: 3708640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 03/23/2017
• Initial Report FDA Received Date: 03/03/2017
• Supplement Report FDA Received Date: 03/23/2017; 03/28/2017; 10/02/2017
• 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: 43 YR