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

Model Number	3889-33
Medical Device Problem Codes	Break (1069); Device Contamination with Chemical or Other Material (2944); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2019
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from the healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who had an implantable neurostimulator (ins).It was reported that the lead was placed on the left side however they were not able to get any motor or sensory response on any electrodes.The live fluoroscopy showed that the tip of the lead was hitting something because it was curling up.The healthcare professional (hcp) reloaded the lead trying to steer it to the correct position but after testing again multiple times, hcp decided to try the left side.Upon loading the lead into the introducer hcp noticed there was blood inside the lead.At that point hcp realized it was broken after electrode 0.A new lead was loaded and all correct sensory and motor responses were achieved.Lead will be returned back to medtronic.No further complications were reported or anticipated.
Additional Manufacturer Narrative
Analysis of lead model 3889-28 lot # va20pjt showed that the distal end of the lead was bent.Electrical testing showed the continuity was complete and no electrical shorts were seen between the circuits.The lead device was subjected to a series of standard tests that included but not limited to visual inspection and electrical testing.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: 8912215
• Report Number: 2649622-2019-14766
• Device Sequence Number: 526190
• Product Code: EZW
• UDI-Device Identifier: 00643169864443
• UDI-Public: 00643169864443
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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: 06/21/2023
• Device Model Number: 3889-33
• Device Catalogue Number: 3889-33
• Device Lot Number: VA20PJT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 68