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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Unable to Obtain Readings (1516)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Event Description

It was reported that patient experienced loss of therapeutic effect.The patient claimed that they did not see good symptom control from date of implant.The patient complained of not feeling stimulation for about a year since implant.The patient had a worsening of urinary symptoms recently.The patient was programmed with 3+ 0- at a voltage of 2.3v.The following impedances were reviewed: c0: 1226 c1:??? c2: 1111 c3: 628, 01 1482 02: >4000 03: 2213.The health care provider wanted to help programming around an elevated impedance value.The patient was programmed to c+ 3- pulse width: 210us rate: 14 hz and confirmed that patient felt stimulation at a voltage of 1v.No outcome was reported regarding this event.A further follow-up is being conducted to obtain this information.A follow-up report will be sent if additional information becomes available.

Manufacturer Narrative

Concomitant medical products: product id 3037, serial# (b)(4), product type: programmer, patient; product id 3 093-33, lot# v508248, implanted: (b)(6) 2010, 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: 4519508
• MDR Text Key: 19803006
• Report Number: 3004209178-2015-03056
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2015

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: 12/14/2011
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 02/16/2015
• Date Device Manufactured: 06/23/2010
• 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: 00061 YR