MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)

Patient Problems Pain (1994); Malaise (2359); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The consumer reported via a manufacturer representative (rep) that she was sick, grabbed some ice packs, and laid down.In 30 minutes, she had sharp pains and an electrical shock going into the vaginal area.It hurt so bad that she was screaming every time it pulsed.The stimulation was at 1.9 volts and she turned to down to 0.9 volts.The stimulation was tolerable again.The pain slowly diminished to nothing.They went to the emergency room and x-rays showed no movement or damage to the lead.There were no loose leads.It was unknown what led to the event.There were no diagnostic/troubleshooting or actions/interventions performed yet.The issue was not resolved at the time of the report.The rep was going to see the patient on (b)(6) 2016 to interrogate the device.Surgical intervention did not occur and was not planned.It was further reported on (b)(6) 2016 that the rep was with the patient and it was related to the device.The cause of the event was unknown.She told the rep that she had chronic stomach issues and the illness was not uncommon.However, the painful stimulation had never happened before.The patient denied any falls or any other incidents that would have damaged the device.The rep ran impedance tests 3 times.The first was at 1.0 volts and 210 pulse width.The second was at 1.5 volts and 270 pulse width.The third was at 2.0 volts and 330 pulse width.Every time, all the leads came up with abnormal impedance except the 2 and 3 electrode combination.The patient came in on 0-,3+ and by the history, it looked like she had only been on this program.The battery test was inaccurate due to the abnormal lead impedance.The rep and patient were going to discuss with the health care professional (hcp) about replacing this lead and battery.The indication-for-use (ifu) was gastrointestinal/pelvic floor.Further follow-up is being conducted to determine if a lead or implantable neurostimulator (ins) replacement was scheduled and whether or not this resolved the issue.If additional information is received, a follow-up report will be sent.Refer to regulatory report #3004209178-2016-03226 for information on the patient's other ins.

Event Description

Additional information received from the manufacturer representative (rep) in response to follow-up reported that the replacement had not been scheduled yet.They were working to get her on the schedule for (b)(6) 2016.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5451311
• MDR Text Key: 39144469
• Report Number: 3004209178-2016-03227
• Device Sequence Number: 1
• Product Code: LNQ
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2016

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: 10/14/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2016
• Date Device Manufactured: 04/17/2013
• 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: 00041 YR