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

Model Number 3058

Device Problems Break (1069); Human-Device Interface Problem (2949)

Patient Problem Scar Tissue (2060)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot#: va20njy, implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead.Product id: 3889-28, serial/lot #: (b)(4), ubd: 19-jun-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a healthcare provider (hcp) via a manufacture representative (rep) regarding an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.The rep spoke with the patient preoperatively.The patient stated that therapy was working well.The rep looked at the patient programmer for stage 1 and saw that it was turned off.The rep wanted to set the new programmer the same since therapy was working so well.The programmer was set to program 2.The rep turned therapy on program 2 and increased stimulation for the patient to tell the rep when they felt the stimulation.The patient felt stim at 5.2.When in the or, the hcp opened the pocket to attach the ins.The boot was visible without the extension connector and four screw unit attached with wiring exposed.The hcp had to manually loosen the extension set from scarred tissue around the wiring and exposed the extension set.When the screws were removed and the lead tip exposed, the lead's internal wiring was also exposed.The lead was then removed and replaced with a new lead with responses to all electrodes and attached to an ins without impedance.The issue is resolved.

• Brand Name: INTERSTIM II
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9473995
• MDR Text Key: 178309298
• Report Number: 3004209178-2019-23861
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2019
• Date Device Manufactured: 06/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 136