MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 05/10/2022

Event Type  Injury  

Event Description

Woke from sleep by sharp shock in area of interstim ii lead (left hip) when turning over in bed.Checked interstim multiple programming options and found stimulation occurring only in left buttock, not in areas previously stimulated.Turned off stimulation until i saw my doctor.Bulge under skin observed in area of lead over left si joint.On (b)(6) 2022, physician ((b)(6), md) recommended removal of interstim and lead.Surgical explant scheduled for (b)(6) 2022.S/n interstim: (b)(4) (per wallet card) s/n lead: (b)(4) (per continuity of care document).Fda safety report id# (b)(4).

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 15055150
• MDR Text Key: 296227757
• Report Number: MW5110946
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/14/2022

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: Lay User/Patient
• Device Expiration Date: 02/08/2023
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2022
• Patient Sequence Number: 1
• Treatment: ALLERGY VACCINE; ANKLE REPAIR; BILATERAL HIP REPLACEMENTS; CO Q-10; CURRENTLY WITH INTERSTIM II, SCHEDULED TO BE EXPLANTED (B)(6) 2022.; EZETIMIBE; FAMOTIDINE; FLUTICASONE; FUROSIMIDE; K-TAB ER; MAGNESIUM; MVM; NICOTINIMIDE RIBOSIDE; OMEGA-3; VITAMIN D-3
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White