MAUDE Adverse Event Report: IPG MFG SWITZERLAND INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 7427T

Device Problems Break (1069); Failure to Deliver Energy (1211); High impedance (1291); Unable to Obtain Readings (1516); Difficult to Remove (1528); Low impedance (2285); Device Or Device Fragments Location Unknown (2590)

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

Event Type  Injury  

Event Description

It was reported the patient experienced both a loss of therapeutic effect and loss of stimulation.High impedances were measured on both leads.All electrode combinations except 4 and 5, 4 and 7, and 5 and 7 measured to be greater than 4,000 ohms.Those three electrode combinations had an impedance measurement of 64 ohms.Therapy impedances for programs 1 and 2 displayed as ¿???.¿ in addition, x-rays were taken.It was noted that both leads were broken directly in front of the extension connector blocks.A procedure to implant new leads was done.The contacts of both leads were still in the connector blocks.The extensions did not appear to be damaged, but the doctor did not want to manipulate them, so the extensions were removed as well.The leads were the only things visibly damaged.One of the leads was also cut during the procedure close to the tine.One lead could be completely explanted, but a piece (little ball/radiopaque marker above the tines) of the other lead could not be explanted.Therefore, it was partially explanted.The implantable neurostimulator was verified to have operated normally.No further information was reported.A follow up report will be sent if additional information is received.

Manufacturer Narrative

Comcomitant: product id 388928, lot# 0205756279, implanted: 2012-(b)(6), explanted: 2015-(b)(6), product type lead.Product id 388928, lot# 0205827331, implanted: 2012-(b)(6), explanted: 2015-(b)(6), product type lead.Product id 3095-10, serial# (b)(4), implanted: 2012-(b)(6), explanted: 2015-(b)(6), product type extension.Product id 3095-10, serial# (b)(4), implanted: 2012-(b)(6), explanted: 2015-(b)(6), product type extension (b)(4): analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Analysis of the tined lead ((b)(4)) found that all conductors were broken (overstress/damage) 2.0 cm from the proximal end with the outer insulation separated at the butt joint.All conductors were also broken (overstress/damage) at about the midpoint of the lead.The lead was very twisted, causing stress on the conductors and the insulation.The lead was cut and segmented 5.3 cm from the distal end.Analysis of the tined lead ((b)(4)) found that all conductors were broken (overstress/damage) 2.5 cm from the proximal end with the outer insulation separated at the butt joint.Conductor #3 was broken at the electrode #3 weld site.The lead was very twisted, causing stress on the conductors and the insulation.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• 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: 4807705
• MDR Text Key: 5896499
• Report Number: 9614453-2015-01063
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/08/2015

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: 07/28/2013
• Device Model Number: 7427T
• Device Catalogue Number: 7427T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2015
• Initial Date FDA Received: 05/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/29/2015
• Supplement Dates FDA Received: 06/09/2015; 07/29/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2012
• 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): Other; Required Intervention