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

Model Number 3058

Device Problems Unsealed Device Packaging (1444); Device Operates Differently Than Expected (2913)

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

Event Date 12/18/2013

Event Type  malfunction  

Event Description

It was reported that during a procedure to implant the implantable neurostimulator (ins), upon opening of the, it was observed that the screw driver accessory was ¿poking¿ through the sterile packaging.The physician concluded that they may be a loss of sterility to the implant device and they elected not to use this ins.The component was removed from sterile field and a new ins device was then used.It was noted that the effected ins did not come in contact with the patient or the sterile equipment as they were changed before the procedure continued.There were no reported patient injuries as a result of the event.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: chad hedlund ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149619
• MDR Report Key: 3568534
• MDR Text Key: 4078690
• Report Number: 3004209178-2014-00525
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2013
• Initial Date FDA Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2013
• 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
• Patient Age: 00080 YR