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

Model Number 3058

Device Problems High impedance (1291); Unintended Collision (1429); Unable to Obtain Readings (1516); Insufficient Information (3190)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are product id: 3093-28, lot# va0p3s7, implanted: (b)(6) 2014, product type: lead.Other relevant device(s) are: product id: 3093-28, serial/lot #: (b)(4), ubd: 10/01/2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer 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 health care professional (hcp) was seeing "???" on the longevity.Hcp tested impedance at 2.5volts and 210pw: and c0 4k ohms, c1 4k, c2 1034 ohms ,c3 4k, 01 4k , 02 4k, 03 4k ,12 4k, 23 4k ohms.It was also reported that the patient had multiple falls which lead to lead issue and loss of therapy.No further complications were noted or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received and mdt rep stated that eh cause of the high impedance and ??? was not determined and that the patient has a history of multiple falls.They also stated that the cause of the lead issues was likely cause by the falls.Multiple attempts were made to clear the impedance but was unsuccessful and that the patient was going to be scheduled for a full system revision for a later date and as of now the device was still in use.The date of the revision was not yet known.No further complications were noted or anticipated.

• 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: 8599333
• MDR Text Key: 144690315
• Report Number: 3004209178-2019-09345
• 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
• Report Date: 06/06/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 06/04/2019
• Supplement Dates FDA Received: 06/06/2019
• Date Device Manufactured: 07/24/2014
• 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