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

Model Number 3058

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Electromagnetic Compatibility Problem (2927)

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

Event Date 06/27/2014

Event Type  Injury  

Event Description

It was reported that the patient had a power on reset (por) condition following emi exposure.The patient had turned stimulation off for surgery yesterday and saw the por today when they tried to turn stimulation back on.Additional information received reported that the manufacturer representative didn¿t have the answers yet and the patient was meeting them at their health care provider¿s (hcp¿s) office on (b)(6) 2014 for an impedance test.Additional information received reported that the patient¿s surgery was related to their therapy as it was a device implant for their bladder.The manufacturer representative was not sure what caused the por and the patient was not experiencing any symptoms.It was noted that the impedance test was giving them questions marks on electrodes 1 and 3.They were able to program the patient once they were out of the operating room (or) and the patient was doing well.

Event Description

Additional information received reported that the patient only had 1 implant.The first surgery was a stage 1 and the second surgery was the implant of the neurostimulator.

Manufacturer Narrative

Concomitant medical products: product id 3037, serial# (b)(4), product type: programmer, patient; product id 3 889-33, lot# va045as, implanted: (b)(6) 2013, product type: lead.(b)(4).

• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3941508
• MDR Text Key: 4597462
• Report Number: 3004209178-2014-13173
• Device Sequence Number: 1
• Product Code: EZW
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2014

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: 02/28/2015
• 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: 08/21/2014
• Initial Date FDA Received: 07/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/28/2014
• Date Device Manufactured: 09/12/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 00066 YR