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

Model Number 3058

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inadequate or Insufficient Training (1643); Device Operates Differently Than Expected (2913)

Patient Problems Edema (1820); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Tingling (2171); Discomfort (2330); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor patient ins was implanted to treat urinary retention.It was reported that the patient experienced uncomfortable stimulation and that they did not received adequate training due to being under anesthesia.Patient also reported that something was going on with their body and did not know if she had strong stimulation or the correct program.The further mentioned that the felt strong pulse in feet and legs and it felt like beating fast which made it hard to sleep.Patient stated that they set the amplitude at 0.7 and it seemed comfortable but the whole right side was achy like arthritis or something in my body.Patient also reported that it felt like their knee cap has double the size and maybe causing water retention in their knees and thighs which is painful.Patient went on to report that they were sore and could hardly move.Amplitude was decrease to.5 and patient reported that they felt numbness in their legs, back and knee.They also reported tingling sensation in the whole right side , feet knee and buttock and back.Amplitude was further decreased to.4 and patient stated that it was better for them.No further complications were noted or anticipated.

• 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: 7400572
• MDR Text Key: 104727377
• Report Number: 3004209178-2018-06584
• 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
• Report Date: 04/05/2018

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: 06/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 04/05/2018
• Date Device Manufactured: 12/21/2017
• 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 Age: 57 YR