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

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problems Foreign Body Reaction (1868); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3058, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor who reported that the patient previously had 2 of the 4 implants they have had "[work] their way out of the body," but the patient was not sure which implants they were or when this occurred.Patient status is unknown at the time of this report.There were no further complication reported or anticipated.

Manufacturer Narrative

(b)(4): if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received and it was reported that patient did not now what circumstances led to the device working its way out and they thought their body tried rejecting it, so it was removed and replaced and the issue resolved.

Manufacturer Narrative

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

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7694628
• MDR Text Key: 114675997
• Report Number: 3007566237-2018-02108
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

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 Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 07/17/2018
• Supplement Dates Manufacturer Received: 08/06/2018; 08/08/2018
• Supplement Dates FDA Received: 08/24/2018; 10/05/2018
• Was Device Evaluated by Manufacturer?: No
• 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 Weight: 73