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

Model Number 3058

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and the other applicable components are: product id: 3889, product type: lead.

Event Description

Information was received from a healthcare professional (hcp) regarding patient who was implanted with a neurostimulator.It was reported that, during removal of the device, the surgeon noted a lead fracture.The lead fracture resulted in a portion of the tined lead being retained in the patient.There were no further complications reported or anticipated.**see attached medwatch mw5072172**.

Manufacturer Narrative

There are no longer any adverse events associated with the event.It was determined that the device was removed for the purpose of having mri's and therefore no serious injury occurred with the system.Product id: 3889.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare provider reported that the patient was having surgery for a hysterectomy that was unrelated to the device or therapy.They wanted to have the device removed, while in that surgery, so they could have mri's for their pre-existing conditions.The hcp stated that notes from the operations said that the left lead and device were explanted fully, but on the right boot there was a fracture of the distal tines causing them to not be able to remove the lead.There were no plans to try to remove the lead in the future.The patient's pre-existing conditions included paraplegic due to a fall from a tree and t11 fracture, pelvic organ prolapse, and urostomy.They also noted that the device was still being held in pathology and that a rep was not present at the time of the 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 MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6922064
• MDR Text Key: 88417134
• Report Number: 3007566237-2017-04223
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

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: 03/28/2018
• 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: 10/02/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 10/24/2017
• Date Device Manufactured: 10/12/2016
• 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: 51 YR
• Patient Weight: 68