MAUDE Adverse Event Report: MEDTRONIC, INC. INTERSTIM ICON; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	3037
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Codes	Incontinence (1928); Therapeutic Response, Decreased (2271)
Date of Event	10/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 3058, serial#: (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.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.
Event or Problem Description
A patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor reported a loss of therapy.The patient stated that the patient programmer (pp) has not been working/not turning on for about one week and that about a week ago the patient began to have accidents and wanted to use the pp to adjust the setting.Replacement of the pp batteries resolved the pp issue and the patient stated that she would adjust her stimulation.Troubleshooting resolved the pp issue.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM ICON
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6087031
• Report Number: 2182208-2016-02593
• Device Sequence Number: 1666126
• Product Code: EZW
• UDI-Device Identifier: 00643169512955
• UDI-Public: 00643169512955
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2016

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: 3037
• Device Catalogue Number: 3037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2016
• Supplement Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 11/08/2016
• Supplement Report FDA Received Date: 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: 76 YR