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

Model Number 3058

Device Problems Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Therapeutic Effects, Unexpected (2099); Urinary Frequency (2275)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient reported through a manufacturer representative that they experienced ¿poor curative effect¿ and that they ¿almost had no effect¿ after implant as of (b)(6) 2018.The patient¿s ¿postoperative improvement was not ideal¿ and their ¿experience effect was not as good as that of the first phase.¿ though the patient noted the fist phase of the experienced was good, following implant the patient had ¿no effect¿ despite 10 programming attempts.It was unknown if any additional actions were taken besides programming.Though the patient was implanted for uroschesis/retention, the patient experienced urinary frequency after implant.The patient¿s ¿urination needed to be conducted within an hour.¿ it was noted that more than 50% of the patient¿s symptoms were not reduced.The ¿life of the patient caused great bitter pill¿ and ¿affect the normal life.¿ the cause of the issue was unknown.Additional information received reported the ¿patient¿s postoperative symptoms did not improve satisfactorily¿ as of (b)(6) 2019 and that it was ¿suspected to be a problem with the quality of the device.¿ it was noted the device was ¿ready to be explanted in the surgical hospital on (b)(6) 2019.¿ the patient was being observed at home at the time of report; no further complications were reported or anticipated.

Manufacturer Narrative

Product id 3889, lot# unknown.Product type lead.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.

Event Description

Additional information received reported the ins was explanted as planned on (b)(6) 2019.It was unknown how the patient was as of (b)(6) 2020.There were no further complications reported or anticipated.

Manufacturer Narrative

Product id 3889, lot# unknown.Product type lead.Analysis of the ins (s/n: (b)(4)) found insignificant anomalies with the device.Analysis of the lead (s/n: unknown) found the outer insulation was separated at a butt joint at the distal end.Fdc pertains to the ins (s/n: (b)(4().Fdm and fdr pertain to the ins (s/n: (b)(4)).Fdc pertains to the lead (s/n: unknown).Fdm and fdr pertain to the lead (s/n: unknown).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: 9565281
• MDR Text Key: 174181284
• Report Number: 3004209178-2020-00491
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P970004
• 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
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2016
• 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: 69 YR