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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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MEDTRONIC, INC. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE Back to Search Results
Model Number 3889-28
Device Problems Leak/Splash (1354); Electronic Property Issue (2928)
Patient Problem Pain (1994)
Event Date 08/21/2017
Event Type  malfunction  
Event Description
She had anterior and posterior prolift meshes that we have removed.She has stool incontinence with urgency incontinence.After the interstim insertion, she greatly improved her symptoms.The urgency and frequency of urine and stool were practically gone.Unfortunately, she developed progressively significant pain over the device.The device was turned off and the pain disappeared.A diagnosis of electrical leak was made and the device had to be removed.In the future, if desired, we will insert another device.
 
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Brand Name
INTERSTIM
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
Manufacturer (Section D)
MEDTRONIC, INC.
710 medtronic pkwy.
minneapolis MN 55432
MDR Report Key7120554
MDR Text Key94944932
Report Number7120554
Device Sequence Number1
Product Code KPI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/11/2017
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
Device Operator Physician
Device Model Number3889-28
Device Catalogue Number3889-28
Device Lot NumberVA1BVE6
Other Device ID NumberMP6860 LEAD, 4 ELECTRODE 28CM
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/11/2017
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer12/11/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/15/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
OTHER DEVICES: I DO NOT KNOW.
Patient Age69 YR
Patient Weight68
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