MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	3058
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 3889-28, lot# va1dtab, implanted: (b)(6) 2017, product type lead.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
Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was being implanted with a neurostimulator for urinary incontinence.It was reported that, during the full implant, it was noticed that the percutaneous extension in the lead kit was frayed.This was not needed for the procedure.It was one of the kit components, but it was defective.It was noted that the issue was resolved.There were no symptoms reported.
Additional Manufacturer Narrative
The main component of the system and the other applicable components are: product id 3889-28, lot # va1dtab, implanted: (b)(6) 2017, product type lead; product id neu_perc_extension, lot # unknown, product type extension.Analysis of the percutaneous extension found that, at the distal end, the connector was twisted in the molded rubber.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM II
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 6303614
• Report Number: 3004209178-2017-02594
• Device Sequence Number: 303200
• Product Code: EZW
• UDI-Device Identifier: 00613994601957
• UDI-Public: 00613994601957
• Combination Product (Y/N): N
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided; 02/16/2017
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 02/23/2017; 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR