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

Model Number 3058

Device Problems Break (1069); High impedance (1291); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Info references the main component of the system and other applicable components are: product id 3889-28, lot# v644605, implanted: (b)(6) 2011, explanted: (b)(6) 2017, product type lead.

Event Description

Information was received from a consumer via a manufacturer representative regarding a patient implanted with an implantable neurostimulator (ins).It was reported that the lead had an impedance over 4000 ohms on the 0 <(>&<)>2 and 0<(>&<)>3 electrode combinations.When the battery was removed from the pocket, the sheath on the lead was sliding back from the battery insertion point.Lead was partially removed and replaced on the other side, but the lead broke during explant between the 2nd and 3rd time.It was noted that an impedance check was performed and the issue was resolved.No further complications were reported.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis #702254584:analysis information -- 2018-03-15 16:17:01 cst pli# 20 product id# 3058 the implantable neurostimulator (ins) passed functional testing.Due to the reported complaint, an impedance test was performed in 0.9% saline solution and good impedances were observed using an n'vision clinician programmer.A lab functional test determined there was good stable output on the electrode pairs the ins had when it was received.A lab functional test determined there was good stable output on all electrode pairs.Analysis determined there were no issues when pressing on the ins can.Analysis determined the telemetry was acceptable.Analysis determined there was a lead or lead parts stuck inside the ins connector port.Continuation: product id 3889-28 lot# v644605 serial# implanted: 2011 (b)(6) explanted: 2017 (b)(6) product type lead.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis identified the outer insulation of the lead was separated at the butt joint near the proximal end of the lead.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Analysis observed the connector(s) of the lead were crushed.During visual analysis of the lead, it was noted the distal end was not returned.Analysis identified markings on the outer insulation of the lead which is consistent with markings from the use of a tool.Analysis determined conductor wire(s) were broken due to overstress/damage.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7125387
• MDR Text Key: 95175869
• Report Number: 3004209178-2017-26146
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2012
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 02/26/2018; 03/29/2018; 03/29/2018
• Supplement Dates FDA Received: 03/06/2018; 03/29/2018; 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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 Outcome(s): Required Intervention