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

Model Number 3058

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling (2091); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy, overactive bladder.It was reported that the patient had to take antibiotics because there was inflammation at the implant site and it was swollen.When the inflammation went down, the lead poked out, meaning it was very visible under the surface of the skin but the skin was healed over the top of it.It was noted that when the patient bends over, it hits their pants, and is right at their waistline.The patient's doctor said it's due to the patient's lack of fatty tissue, and will stay like that. the patient also stated that it hurt 2-3 weeks after implant and they couldn't sit or sleep, but that had passed.The implant site was not bad, but the scar is tender and also puffy. they also reported that they were getting some relief from their symptoms, but last week it all changed; they were almost back to where it was prior to implant.They had urinary incontinence in a store and it ran down their leg.Troubleshooting on the call included reviewing therapy, and the patient increased amplitude from 0.5 to 0.7 and noted that they would try this first before changing programs.It was recommended that they monitor their symptoms after making the change, and make additional adjustments based on their symptom results.

• 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: 10685501
• MDR Text Key: 211653003
• Report Number: 3004209178-2020-18039
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/15/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/15/2020
• Date Device Manufactured: 02/25/2019
• 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: 47 YR
• Patient Weight: 64