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

Model Number 3116

Device Problems Unintended Collision (1429); Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Event Description

Additional information received later indicated that patient was getting 50% or greater symptom reduction.The cause of the event was determinant as not device related.It was noted as unknown if reprogramming was needed.The patient outcome was reported as unknown.It was noted that health care provider had not seen patient since the accident.

Event Description

It was reported that a patient was in a motor vehicle accident about a month prior to the report and was hit right on top of the device.The patient had a hematoma right over the device.Prior to the accident her symptoms were great, but since the accident they were returning, there was a loss of therapeutic effect, and the patient felt it wasn¿t working as well.The impedance and voltage markers on the clinician programmer were showing question marks.Impedance was measured with the clinician programmer antenna over the implant and the values showed 716 ohms and 3.6 volts, which seemed to indicate a healthy lead.The values in the box below the settings were 6 volts and 420 microseconds.X-ray imaging was done and the system seemed to be in a good position.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain additional information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant products: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type lead; product id 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type lead.(b)(4).

• 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: 4193782
• MDR Text Key: 4986247
• Report Number: 3004209178-2014-20186
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2014

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: 02/28/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 10/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2014
• Date Device Manufactured: 09/06/2013
• 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 Age: 00015 YR