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

Model Number	3058
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pocket Erosion (2013)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer via a manufacturer representative regarding patient with an implantable neurostimulator (in s) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient's incision opened and the lead was exposed through the incision.It was reported that the patient was implanted on (b)(6) 2019 and the exposed wire was reported on (b)(6) 2019.It was noted this was observed by the patient and their friend and the doctor's office had been contacted.It was reported the issue was not resolved at the time of the report.Additional information was received from the healthcare provider via the manufacturer representative (rep).The rep reported they got an update from the physician, dermabond glue covering the lead/skin incision opened up and part of the lead was exposed.The patient was seen the wednesday prior in the physician's office, the incision was closed again with a suture and 2 days of keflex was initiated.No further complications were reported or anticipated.
Additional Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id 3889-33 lot# va1va0m implanted: (b)(6)2019.Product type lead.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: 8240919
• Report Number: 2649622-2019-00694
• Device Sequence Number: 2279708
• Product Code: EZW
• UDI-Device Identifier: 00643169864443
• UDI-Public: 00643169864443
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Device Lot Number: VA1VA0M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 01/11/2019
• 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: 81 YR