MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Break (1069); Unintended Collision (1429); Device Or Device Fragments Location Unknown (2590); Impedance Problem (2950)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot# va14lca, implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received regarding a patient implanted with a neurostimulator (ipg).Health care professional reported the patient was no longer experiencing relief of their oab symptoms.The patient¿s device was interrogated and they ¿found impedance on a number of the electrode combinations.¿ it was reported that the patient is a very active (b)(6) and has experienced many falls that could have caused the impedance.The health care professional replaced the lead and the ipg on (b)(6) 2018 however the lead fractured as they tried to remove it.The tines and distal electrodes remain in the patient.No further complications reported/anticipated.

Manufacturer Narrative

Device received, analysis not yet complete.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received.Some of the electrodes had impedances over 4000ohms.No further information reported/anticipated.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) ((b)(4)) revealed no anomalies were identified.Analysis of the implantable lead (va14lca) revealed no anomalies were identified.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 7348330
• MDR Text Key: 102724800
• Report Number: 3004209178-2018-05231
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/16/2018

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: 08/14/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 03/21/2018; 04/16/2018; 04/30/2018
• Supplement Dates FDA Received: 03/22/2018; 04/20/2018; 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2016
• 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: 18 YR
• Patient Weight: 64