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

Model Number 3058

Device Problems Energy Output To Patient Tissue Incorrect (1209); Energy Output Problem (1431); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Improper Device Output (2953); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Discomfort (2330); Electric Shock (2554)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: product id 3889-33, lot# va0wtzm, implanted: (b)(6) 2017, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 3889-33, serial/lot #: (b)(4), ubd: 15-jun-2019, udi#: (b)(4).Evaluation conclusion code pertains to both ipg 3058 interstim ll ((b)(4)) and tined lead, 3889-33, interstim ((b)(4)).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a healthcare professional (hcp) regarding a patient implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported the hcp stated the patient came in and complained of constant pulsing, shocking, burning, pain, and discomfort in the lower right back.The hcp stated they sent the patient for an x-ray but hadn¿t done much beyond that as far as evaluation of the system.The hcp stated the patient was scrubbing the shower on (b)(6) and felt a ¿pop¿ in the middle of their lower back.The hcp stated the patient indicated she could turn one of the leads off, but the other can only get to 0.6 v before the issue was present.It was noted the patient had a ¿pop¿ in the back on (b)(6) they had burning, shocking, and pulsing.The hcp noted that since (b)(6) the issue had gotten progressively worse.Additional information from the hcp on (b)(6) reported she spoke to the patient and the stated they could not turn off the ins, but the hcp didn¿t know if it was an issue or what the patient was seeing on their patient programmer.Additional information from the patient on (b)(6) reported they were having a lot of problems, the patient further stated her device was shocking her and she could not turn her device off.The patient stated she went to the hcp office and they tried, but they got lead two to shut down the whole way but lead one would not.The patient stated on (b)(6) her other stuff had started and that now the site was sore and tender where the implant was located.The patient stated it was burning badly and it was a constant pulse coming out.The patient confirmed the patient programmer showed the implant was off and confirmed she was on program 2 at 0.0 v.The patient changed to program 1 at 0.6 v and she could not decrease stimulation, she was still getting the sync now screen.Patient services review and the patient was able to decrease stimulation to program 1 at 0.0 v and she confirmed she was still feeling the pulsing even though the stimulation was at 0.0 v and it was off.The patient stated everything started on (b)(6), but not nearly as bad as it was at the time of the call.The patient stated the burning and constant pulsing began on (b)(6).The patient noted the burning at the lead started on (b)(6).There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: 3889-33, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4).(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the patient wasn't sure what the cause was and she called her health care professional and had her shut it down.The patient also stated that she wasn't feeling the shocking anymore since the device was turned back on but the burning and soreness returned.There were no further symptoms or complications reported or anticipated.

Manufacturer Narrative

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: 7646969
• MDR Text Key: 113014514
• Report Number: 3004209178-2018-14589
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

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: 06/14/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 07/16/2018; 08/08/2018
• Supplement Dates FDA Received: 07/25/2018; 10/03/2018
• Date Device Manufactured: 12/15/2016
• 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 Age: 49 YR
• Patient Weight: 114