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

Model Number 3116

Device Problems Break (1069); High impedance (1291); Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem Adhesion(s) (1695)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2001, explanted: (b)(6) 2016, product type: lead.Product id neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2001, explanted: (b)(6) 2016, product type: lead.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

The manufacturer representative reported that the patient had diabetic gastroparesis.The stimulator failed and the resistance in the system had gone over 800 ohms, suggesting that one of the leads had fractured.The leads had fractured and were the original leads that were many years old.The patient¿s prior stimulator and leads were removed and a new stimulator and leads were implanted on (b)(6) 2016.There were omental adhesions in the upper abdomen and they were around the leads.It was with some difficulty that the health care provider (hcp) exposed the leads and followed them down to the stomach.They entered the stimulator pocket and removed the stimulator through the same incision.The hcp interrogated the system and confirmed that the system was not working.They removed the stimulator from the leads and then removed the leads from the stomach.The new leads were inserted and were tunneled to the pacer pocket.The hcp attempted an upper gastrointestinal (gi) endoscopy, but was not able to complete this as they could not get the endoscope to pass through the cricopharyngeus.A new pacer was attached and they interrogated the system.The resistance in the system was 506 ohms and it was set to nominal positions.It was in the on position.The wound was irrigated and the pocket was closed.The patient was brought to recovery in good condition and there were no complications.The indication for use for this patient was gastric pacing.

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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6033636
• MDR Text Key: 57618253
• Report Number: 3004209178-2016-21876
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2016

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: 05/14/2008
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/17/2016
• Supplement Dates Manufacturer Received: 09/21/2016
• Supplement Dates FDA Received: 09/26/2017
• Date Device Manufactured: 11/22/2006
• 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