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

Model Number 3058

Device Problems Unable to Obtain Readings (1516); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot# va18qmc, implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: va18qmc, ubd: 19-jul-2020, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer representative regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor and bowel dysfunction/sacral nerve stim.It was reported that the patient had already had program changes and stated, ¿it¿s not working.¿ impedance was checked by the rep in the or and the case electrodes were coming out with ¿???¿ with 2.2v and 330 pulse width and increasing the power did not drop them off.It was noted that the patient was getting bellow, motor response.It was clarified that they were getting motor response at 1.2 or less on all electrodes; they got bellows, motor response, with all the case electrodes programmed at 1v.It was also stated that the therapy impedance with c+3- was 1004 ohms and less than 15ma.The lead was replaced, and it was noted that the issue was resolved.No further patient complications are anticipated or expected as a result of this event.

Manufacturer Narrative

Review of new information determined that the previously reported impedance issues occurred after the lead revision, and are thus not related to this lead or event.The event description and coding have been changed.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer representative regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor and bowel dysfunction/sacral nerve stim.It was reported that the patient stated the therapy was not working.They had already had program changes and stated, ¿it¿s not working.¿ no device issues were noted; the battery life was greater than 85 months, impedance checks were all within normal limits, and the patient felt stimulation.The lead was replaced, and it was noted that the issue was resolved.There were no device issues reported, and no further patient complications are anticipated or expected as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative.It was reported that the reason for the lead revision was that the patient was not getting symptom relief.No further patient complications are anticipated or expected as a result of this event.

• 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: 8160384
• MDR Text Key: 130212857
• Report Number: 3004209178-2018-27570
• 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: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 12/14/2018; 12/18/2018
• Supplement Dates FDA Received: 12/18/2018; 12/19/2018
• Date Device Manufactured: 07/11/2016
• 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: 76 YR