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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Human-Device Interface Problem (2949)

Patient Problems Micturition Urgency (1871); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare provider for a clinical study reported via a manufacturing representative that there was a lack of stimulation on (b)(6) 2015 with perineal pain and urgencies.Neither diagnostics nor troubleshooting had been performed.The device was reprogrammed on (b)(4) 2015 and (b)(4) 2016.The event resolved on (b)(6) 2016.It was noted the event was not serious, not related to the procedure, and related to the stimulation and stimulation.Medical history included idiopathic functional incontinence since 2013.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 309328, lot# 0209335724, implanted: (b)(6) 2015-, product type: lead.

Event Description

Additional information received reported a loss of efficacy with return of symptoms.The investigator assessed the event to be related to the stimulation only.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

Product id: 309328, lot# 0209335724, implanted: (b)(6) 2015, product type: lead; product id: 309328, lot# 0209335724, implanted: (b)(6) 2015, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the health care provider (hcp) of a clinical study via a company representative (rep) reporting that the right side ins and lead were not functioning as needed in 2018.This was ¿probably due to expected.¿.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a health care provider of a clinical study via a manufacturer representative reporting that reprogramming was performed.An additional contralateral device was placed on the left side on (b)(6) 2017 as an action to improve the efficacy of the therapy.The right side device system was replaced on (b)(6) 2018.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the health care provider (hcp) of a clinical study via a manufacturer representative (rep) reporting that the ¿electrical power¿ was not sufficient for ¿effective electromagnetic field¿.There was probably a battery depletion (expected) of right ins.

• 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: 6352923
• MDR Text Key: 68136101
• Report Number: 3004209178-2017-04445
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2020
• Date Device Manufactured: 10/23/2014
• 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: 75 YR
• Patient Weight: 64