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

Model Number 3058

Device Problems Failure to Interrogate (1332); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems High Blood Pressure/ Hypertension (1908); Incontinence (1928); Irritation (1941); Pain (1994); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517)

Event Date 10/01/2004

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 regarding their implantable neurostimulator (ins) for gastrointestinal/pelvic floor.Patient said they have sever pain which they are kind of thinking might be related to the isn.They have been put on a high blood pressure medicine in the last 2 weeks, hasn't slept much, and has pain starting from the bottom of the left hip and down to the heel even though the ins is also located on the left hip.The patient said it's almost tugging at the toe and goes to the heel.They added that they have been put on two different blood pressure medicines, but started to have severe coughing after taking the first one so they put them on a diuretic; they are still in pain.The patient said the pain started two weeks ago on the blood pressure medicine lithipril.Within three days of starting the blood pressure pill, they got sever coughing and had to go to urgent care so they changed to losarton potassium.The patient said they were doing well and the coughing went away, but the pain started; it was as bad as going through labor.The consumer continued and said they went to the emergency room (er) where they gave them some kind of pain medicine through their veins; they got relief.They added that their blood pressure was 205 and was 211 the other night.No falls or physical traumas were reported that could be related to this issue, but they went through emotional trauma of post traumatic stress due to spouse's suicide.The call center reviewed possible adverse events and that there is no known interaction between the ins and blood pressure medicine that would cause pain.The patient noted that they have an appointment with a new primary care physician (pcp) to discuss symptoms.The call center also encouraged the patient to make an appointment with their managing urologist.The patient also said they were supposed to go back to the urologist about 2-3 months ago because their battery reached end of service (eos).The patient put batteries in their patient programmer (pp), but couldn't get it to make a connection to the ins.They noted that the ins isn't working, they are going through pads and has never been completely dry.They continued noting that it never worked 100% and maybe 4 or 5 out of 10.The patient added that they were scared to undergo surgery/anesthesia again so they have not followed up yet.As a result of what was reported, they were redirected to their healthcare provider (hcp) to evaluate symptoms and discuss possible removal/replacement.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received.Patient reported the pain starting at ins battery and the doctor thinks it is her sciatic nerve.Patient further stated that she is going to have the device taken out soon because it does not work for her.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received.Patient reported the pain starting at ins battery and the doctor thinks it is her sciatic nerve.Patient further stated that she is going to have the device taken out soon because it does not work for her.No further complications were reported 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: 9571002
• MDR Text Key: 175024118
• Report Number: 3004209178-2020-00685
• 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,Followup,Followup
• Report Date: 01/31/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 01/21/2020; 01/21/2020
• Supplement Dates FDA Received: 01/31/2020; 01/31/2020
• Date Device Manufactured: 07/14/2014
• 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: 56 YR