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

Model Number 3058

Device Problems Break (1069); High impedance (1291); Device Contamination with Chemical or Other Material (2944); Human-Device Interface Problem (2949)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 3889-28, lot# va1kps8, implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer¿s representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.It was reported that the patient was having their lead revised due to not having adequate symptom relief.After the lead was replaced the healthcare provider (hcp) had great difficulty getting the screw back in, that they turned many times, like the screw was stripped.It was reported that the hcp finally got the screw tightened, and when impedance was tested it was high.The hcp eventually got a new ins and the impedance was reported to be good.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative.It was noted that a healthcare professional had told them about the revision.It was reported that it was unknown how the lead contributed to the lack of symptom relief, but the manufacturer representative assumed that it was suboptimal lead placement.No further patient complications are anticipated or expected as a result of this event.

Manufacturer Narrative

Product id 3889-28 lot# va1kps8 implanted: (b)(6)2017 explanted: (b)(6)2018 product type lead.If information is provided in the future, a supplemental report will be issued.- attachment: [702345001_medwatch.Pdf].

Event Description

Additional information was received from a hcp.It was reported that there was a malfunction and the device did not do what it was supposed to do.See attached user facility report.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional.It was reported that the lead contributed to the lack of symptom relief because ¿it had ¿fouled¿ with blood products in sleeve under the insulation,¿ it was noted that that caused the impedances to be high as well.The healthcare professional was not sure what caused the setscrew to be stripped.No further patient complications are anticipated or expected as a result of this event.

Manufacturer Narrative

Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: (b)(6) 2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) indicating that the lead being fouled with blood products was first noticed in surgery, and the cause was not determined.The hcp also clarified that the high impedances were seen before the new ins was used, not after.No further complications were reported.

• 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: 7241493
• MDR Text Key: 99037118
• Report Number: 3004209178-2018-02078
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2018
• Date Device Manufactured: 09/11/2017
• 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: 76