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

Model Number 3058

Device Problems High impedance (1291); Unintended Collision (1429); Pocket Stimulation (1463); Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

It was reported that the patient started falling on the stairs onto the battery four months prior to the report.Shortly after, her symptoms returned suddenly and she felt stimulation in the pocket site.She had less than 50% therapy relief and pain at the device pocket.Multiple impedance checks showed errors; high impedances over 4,000 ohms and ¿???¿ were seen.Reprogramming was performed and a revision would be scheduled at an unknown date.The exact revision date was not known and no patient outcome was reported, so additional information was requested.If additional information is received a supplemental report will be sent.

Manufacturer Narrative

Product id 3093-28, lot# v256966, implanted: 2009 (b)(6); product type lead product id 3037, serial# (b)(4); product type programmer, patient.(b)(4).

Event Description

It was later reported that the high impedance issue was not resolved and the cause was not determined.The cause of the lack of effect and off target stimulation was not determined.It was noted as unsure and could not confirm if impendence issue was caused by fall but lack of stim and return of symptoms did return after fall and impedance was noted.There was no lead fractures noted.They had replacement surgery of lead and battery on (b)(6) 2015.The patient felt comfortable stimulation again after surgery.The manufacturer representative hasn't heard from patient since procedure to confirm if therapy effective for symptoms.

• 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: 4488366
• MDR Text Key: 5562162
• Report Number: 3004209178-2015-01865
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2015

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: 06/28/2013
• 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: 03/16/2015
• Initial Date FDA Received: 02/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2015
• Date Device Manufactured: 01/10/2012
• 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