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

Model Number 97800

Device Problems Overheating of Device (1437); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Fall (1848); Muscle Weakness (1967); Undesired Nerve Stimulation (1980); Pain (1994); Paralysis (1997); Burning Sensation (2146); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)

Event Date 12/19/2022

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that they had a scary episode this morning and concerned could be related to implant.Patient said that they woke up with cramp in right foot and toes, said "felt like a charlie horse." patient said that they did get out of bed to stand on it to relieve, however when tried to relieve the cramp by pushing their heel down said that it threw them down to the floor, patient said was jolted to the floor.Patient said that the setting was only at 0.4.Patient said they could feel sensation going from their toes to their ankle, to their legs, to their thighs, to ribcage up the side of their body and to neck and stopped right below their ears.Later in the call patient said that could feel it slowly going up their body and got weaker however then said when it got to their neck was painful.Patient said was very painful and scary, said was really shaken by the experience, said at the time thought that they were going to be paralyzed or die.Patient said felt going all the way to their neck.During call patient said that now the other foot is cramped a bit.Patient said that it felt more like a nerve instead of a muscle.Patient said was paralyzed for about twenty minutes and couldn't get up.Patient said was laying in a puddle of urine.Patient said that their neck hurts and jaw from the fall.Patient also said that felt a slight burning sensation at the ins site when held the device over the implant so that could pair.Later in the call patient said that if didn't have the implant would thought was having a stroke.Patient said that somehow they were able to turn stimulation off and has called and left a message for managing healthcare provider (hcp).The patient was redirected to their healthcare provider to further address the issue.Patient was directed to keep stimulation off until they consult with and sees managing hcp.Patient said that does have some medication that can take to help manage symptoms somewhat.Patient said will take later in the day, as said can only take two per day.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM X
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16035318
• MDR Text Key: 306008560
• Report Number: 3004209178-2022-16833
• Device Sequence Number: 1
• Product Code: EZW
• 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
• Report Date: 12/22/2022

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: Health Professional
• Device Expiration Date: 03/28/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 12/22/2022
• Date Device Manufactured: 10/13/2022
• 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): Other
• Patient Age: 73 YR
• Patient Sex: Female