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

Model Number NEU_INTERSTIM_INS

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Insufficient Information (3190)

Patient Problems Calcium Deposits/Calcification (1758); Nerve Damage (1979); Urinary Retention (2119); Urinary Tract Infection (2120); Therapeutic Response, Decreased (2271); Anxiety (2328); Distress (2329); Complaint, Ill-Defined (2331); Injury (2348); Malaise (2359)

Event Date 03/01/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information received from a consumer via the manufacturer representative (rep) reported an index accident occurred in (b)(6) 2015.The patient was wearing a seatbelt at the time of the accident.The index accident involved a low velocity impact to the passengers front side, at approximately 15 to 20 miles per hour (mph).It was accepted by insurers that the accident occasioned damage to the patient's left shoulder caused which required substantial surgery, rotator cuff repair.It was further accepted that the system connection had damaged the nerves to my bowel.They now have permanent damage to their lower bowel with no bowel problems prior to the accident.The insurers agreed their bowel was damaged by the accident, following a report by an independent neurologist.These matters were noted as a matter of background only.

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.

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.

Event Description

Additional information was received from the consumer reporting that the device system worked excellently, brilliantly, and was a godsend until the accident.The accident was on the driver¿s front side.The sacral nerve stimulation (sns) was damaged from the accident.Further stated probability of damage, malfunction, disconnection, and displace/migrated caused by the accident.Significant effectiveness of the sns diminished following the accident.The patient has not been well and has suffered repeated infections, which they never had prior to the accident.The patient¿s bowel was injured.Two or three weeks after the accident the patient experienced dramatic deterioration in urological functioning/symptoms, and in physical and emotional confidence.The patient suffered dramatic loss of confidence and considerate mental distress and anxiety.There was fast escalating incidence and alarming frequency of urinary infection, further stated regular urinary infection on a month to six weekly basis.Six months of botox injections were performed after the accident, which vastly improved and established condition prior to the accident but was temporary.In (b)(6) 2015 the patient was potentially diagnosed with bladder stones, which they never suffered before.The patient has to revert to a leg bag.X-ray of the lead on (b)(6) 2018 was unable to determine whether the lead had or had not been displaced or migrated.The patient may need major urological surgery.Past medical history included: tendon injury triggering a neurological change resulting in bladder injury.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 10088231
• MDR Text Key: 192038258
• Report Number: 2182207-2020-00254
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2020

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 Model Number: NEU_INTERSTIM_INS
• Device Catalogue Number: NEU_INTERSTIM_INS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 07/27/2020; 07/27/2020
• Supplement Dates FDA Received: 08/24/2020; 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability