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

Model Number 3058

Device Problems Break (1069); Unexpected Therapeutic Results (1631); Device Or Device Fragments Location Unknown (2590); Compatibility Problem (2960)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Final analysis of neurostimulator model 3058 (lot # njy232421h ) showed ins functionally okay; no significant anomalies.No significant anomaly.Final analysis of lead model 3889-28 showed stim lead distal end conductor broken (overstress/damage).No significant anomaly.

Event Description

It was reported that a lead was damaged during a surgical procedure.All 4 lead electrodes broke off during explant and remained in the patient's body.Broken lead with retained lead fragments was noted.The doctor was wondering if the patient will be able to have an mri.The patient was having interstim system removed today ((b)(6) 2014) by the doctor in order to have mri.An additional reason for the explant was because the implantable neurostimulator (ins) never provided relief of symptoms for the patient.Loss of therapeutic effect, never having therapeutic effect and less than 50% therapy relief were noted.The patient received good therapy during the trial but very little or no therapy after permanent implant.Impedance testing, x-rays and reprogramming were performed.Reporting from 2014-10-16 noted that the patient was in the doctor's office this week.Information was requested from tech services on mri capability with lead fragment in body.

Manufacturer Narrative

Concomitant medical products: product id 3889-28, lot# va0b23d, implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: lead.(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.This device is included in the medical device correction, "unretrieved device fragments models 3093 and 3889 interstim tined lea ds", educational brief/physician communication (december 2010).

• 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: 4208369
• MDR Text Key: 12559619
• Report Number: 3004209178-2014-20554
• 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,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 10/06/2014

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: 01/14/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 10/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2013
• 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: 00070 YR