MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 3889-28, lot# va0875w, implanted: (b)(6) 2013, product type: lead.

Event Description

Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient who was implanted with a neurostimulator for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.It was reported that patient needed mri done therefore the healthcare provider (hcp) went in and explanted the system.They discovered that the lead wire had been cut.Rep also reported that patient had a back surgery in a while back.Rep requested if there are any recommendation on how to retrieve the electrode in the sacrum.Rep reported the c-arm had been done and indicated there were no lead wires in the body but did see the tined.Rep reported the nurse called back and indicated that the radiographic maker for the tined indicated all 4 electrodes are below anterior edge of the sacrum and hcp decided he would not try to retrieve those broken tined.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 6907646
• MDR Text Key: 89476222
• Report Number: 3004209178-2017-20433
• 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,Followup
• Report Date: 11/21/2017

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: 07/28/2014
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/02/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 11/21/2017
• Date Device Manufactured: 01/31/2013
• 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