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

Model Number 3058

Device Problem Battery Problem (2885)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 309328, lot#: 0209713977, implanted: (b)(6) 2015, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from the healthcare professional (hcp) via manufacturer representative (rep) reported an urge incontinence.Factors that may have led or contributed to the issue remain unknown.Actions taken included a reprogramming done.The issue was not resolved.The investigator assessed the event as not serious, not related to procedure, not related to device component and related to the stimulation.Relevant medical history includes idiopathic urinary urge incontinence since 2005.Additional information received reported diagnostics showed a return of urinary leaks due to lack of system efficacy.Additional information received reported that the patient was reprogrammed on (b)(6) 2020.It was noted that the event was resolved (b)(6) 2020.It was noted that the alleged issue was urge incontinence due to battery depletion.It was noted that the ins was replaced on (b)(6) 2020 and reprogramming was completed to resolve the issue.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10815839
• MDR Text Key: 215501925
• Report Number: 3004209178-2020-19644
• 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
• Report Date: 11/10/2020

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: 03/14/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/10/2020
• Date Device Manufactured: 09/18/2015
• 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: 73 YR
• Patient Weight: 80