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

Model Number 3116

Device Problems High impedance (1291); Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id 435135, serial # (b)(4), product type lead.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Analysis of the lead ((b)(4)) found that the lead body conductor was broken and all filars were broken 2.7 cm from the distal end.Additional method code.Result codes have been updated.

Event Description

It was reported that the manufacturer representative was in a procedure last week when they were planning to replace a patient¿s implantable neurostimulator (ins) and lead.They wanted to replace the entire system because the impedance was measuring high, greater than 800 ohms, and impedance had been fluctuating.The patient was not having any therapy issues at the time of system replacement.There were no concerns about the longevity of the ins, but the health care provider (hcp) wanted to send the ins back to take it off their hands.The hcp wanted to make sure the ins had depleted appropriately, but it was clarified that they didn¿t want any analysis done on the ins.Once they were explanting the system, they decided not to implant another new system because the patient was having other unrelated health issues.They decided to wait to put a new system in at a later time.The hcp had already opened up 2 leads and an ins before they decided not to implant a new system.They wanted to send the unused product back.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 435135, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2015, product type lead.Product id neu_unknown_prog, serial# unknown, product type programmer, physician.(b)(4).

Event Description

Additional information received reported that there was high impedance on the lead.The product issue was resolved and it was unknown if the cause of the issue was determined.The lead was already returned.The patient status was alive with no injury.

Manufacturer Narrative

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

• 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: 4791028
• MDR Text Key: 13336749
• Report Number: 3004209178-2015-09577
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/30/2015

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: 07/14/2011
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 05/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 07/09/2015
• Supplement Dates FDA Received: 05/28/2015; 06/12/2015; 06/22/2015; 07/09/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2010
• 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