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

Model Number 3058

Device Problem Human-Device Interface Problem (2949)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Date 08/21/2017

Event Type  Injury  

Manufacturer Narrative

Non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor.The patient reported that she had it put in last year, but since then, she has had to take it out (explant on (b)(6) 2018) because she had a problem with her hip and they could not do an mri.The patient noted that what was odd was when it had been taken out the nerve pain disappeared.The patient stated that plus, it was not working anyway.The patient noted that it could not work because it was so bad, it had been going on 50 years, and ¿you can't stop water¿.The patient noted that the problem started a little after the implant surgery.The patient reported that she got pain in her groin and did not realize it was a problem with her hip.The patient had started using a cane and dragging her leg everywhere.The patient reported that it felt like sciatic pain, and that she had pain right where her ins was.The patient also reported at implant, that her healthcare provider (hcp) had a lot of trouble finding a nerve that would jump when he put it in.The patient noted that she had two kids and thought it (her symptoms) was caused by crohn's, but her hcp said no it was the two big headed babies she had.The patient wanted to know what to do with her patient programmer (pp), patient services reviewed information.No further complications were anticipated/reported.

Manufacturer Narrative

Event date added.Event date was not added on accident in the previous regulatory report.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: 7776998
• MDR Text Key: 116902583
• Report Number: 3004209178-2018-18054
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2018
• Date Device Manufactured: 02/28/2017
• 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: 70 YR