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

Model Number 3058

Device Problems Device Or Device Fragments Location Unknown (2590); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3093-33, lot# v483608, implanted: (b)(6) 2010, product type: lead.Analysis results were not available at the time of this report.A follow-up report will be submitted when analysis is completed.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

Information was received from a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation.It was reported that the lead and ins were removed and a part of a lead was still implanted; the reason for removal was not known.No further complications were reported/anticipated.Additional information was received from a healthcare professional (hcp).It was reported that the implantable neurostimulator (ins) was removed because it was determined to be non-functioning and the patient experienced pain at the implant site.The surgeon carefully worked with but was unable to remove the tip of the lead; they were able to remove the wire.Additionalin formation received on 2017-dec-06 indicated that the ins was removed due to normal battery depletion.No further complications were reported/anticipated.

Manufacturer Narrative

Device code: (b)(4), fdc code: (b)(4), fdm codes: (b)(4), and (b)(4) fdr code: (b)(4) pertain to product id 3058 (b)(4) product type implantable electrical stimulator fdr codes: (b)(4), fdm codes: (b)(4), and (b)(4), fdc code: (b)(4), pertain to product id 3093-33 lot# v483608 product type lead ins: analysis observed no output or telemetry on the implantable neurostimulator (ins) (b)(4) and determined normal battery depletion and that no telemetry was observed with an n'vision clinician programmer.Lead: analysis of the lead that was returned showed it was segmented; however electrical testing of the returned segment(s) determined that continuity was complete and there were no electrical shorts between the circuits.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.During visual analysis of the lead, it was noted the distal end was not returned.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: 7097506
• MDR Text Key: 94191800
• Report Number: 3004209178-2017-25592
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994287724
• UDI-Public: 00613994287724
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

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: 10/28/2011
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2010
• 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
• Patient Age: 69 YR
• Patient Weight: 49