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

Model Number 3058

Device Problems Break (1069); Failure to Deliver Energy (1211); Device Or Device Fragments Location Unknown (2590)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot # va0gkjn, implanted: (b)(6) 2014, product type: lead.The main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot #: va0gkjn, ubd: 21-feb-2018, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor who reported that the patient thought that their ins was off "because it feels off and isn't treating her symptoms." the patient did not have a patient programmer (pp) to check the ins and thus the caller was advised that the patient should follow-up with their healthcare provider (hcp) to have the ins checked.Additional information received on march 16th indicated that the patient's ins was removed on (b)(6) 2018, but "a part of the lead wire broke off and was left inside" the patient.The caller appeared to indicated that the ins was removed because the patient needed an mri and because the device was not helping the patient.Furthermore, the caller indicated that the patient was "having ra and spine issues." the patient was advised to follow-up with their healthcare provider (hcp) regarding mri considerations and the hcp could call the manufacturer for additional information.Patient status is unknown at the time of this report.There were no further complication reported or anticipated.

Manufacturer Narrative

Product id 3889-28 lot# va0gkjn implanted: (b)(6)2014 product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer (con).It was reported that the patient's hcp was not familiar with the fragments of the lead breaking off.

• 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: 7349307
• MDR Text Key: 102771221
• Report Number: 3004209178-2018-05278
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

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: 08/14/2015
• 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: 03/16/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 03/20/2018
• Date Device Manufactured: 02/27/2014
• 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
• Patient Age: 57 YR