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); Unable to Obtain Readings (1516)

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

Event Type  malfunction  

Event Description

It was reported that patient experienced a loss of therapeutic effect from their implantable neurostimulator (ins).It was noted that the patient was still getting symptom relief but had seen minimal change in their therapy and diminished symptom relief for the past year.It was reported that there was no known incident related to this change.In addition, the patient had parkinson¿s disease so it was unsure how that was impacting the therapy.The patient was at 4.5 volts and felt the stimulation.Impedance measurements showed >4000 ohms on all unipolar and bipolar pairs.Therapy impedance measurements, ¿???¿ display was observed.It was noted that the impedance check was run at 2.0, 210 pw.The reporter was going to re-run the impedance check at a higher voltage then was going to speak to the healthcare professional (hcp).The ins battery status showed ¿ok¿ but longevity showed ¿???¿.Additional information was requested but was not available at the time of this report.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Product id 3093-28, lot# v167798, implanted: 2008 (b)(6); product type lead product id 3037, serial# (b)(4), implanted: 2008 (b)(6); product type programmer, patient.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that the patient was last seen by her healthcare provider six months ago and was told that the battery was getting weak.She had a loss of therapy, she woke up soaked, and she leaked a lot.She had symptoms before, but felt they had gotten worse since she had her deep brain stimulation (dbs) device implanted.Before getting the dbs therapy she was still having issues at night, but not during the day.The patient was up to changing her clothes three times a day.She had parkinson's disease so she had fallen on occasion, but nothing that had caused her any damage.Later, the patient received a blank screen when trying to use the patient programmer.It was determined that one of the batteries was placed backwards.After syncing, the patient saw a power on reset (por).She had a call in to the nurse.Further follow-up is being conducted to obtain additional information.If additional information is received, a follow-up report will be sent.

• 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: 3830973
• MDR Text Key: 4449788
• Report Number: 3004209178-2014-09598
• 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,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/05/2014

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: 11/28/2009
• 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: 07/01/2015
• Initial Date FDA Received: 05/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2015
• Date Device Manufactured: 06/06/2008
• 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: 00066 YR