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

Model Number 3116

Device Problems Low Battery (2584); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

Patient Problems Paresis (1998); Scar Tissue (2060); Therapeutic Response, Decreased (2271)

Event Date 12/01/2007

Event Type  Injury  

Manufacturer Narrative

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 gastric stimulation.It was reported that in (b)(6) 2007, the patient¿s battery quit so the implant was replaced in (b)(6) 2008.It was noted the replacement surgery was more difficult because more additional scar tissue was built up than anticipated.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that in (b)(6) 2007, the patient had problems with gastroparesis again and they did not have anyone to interrogate the device, so it was assumed it had stopped working; it was confirmed in (b)(6) 2008 that it had stopped working and explanted in (b)(6) 2008.It was noted that it depleted quickly, but that was expected because the settings were set pretty high.They noticed excess scar tissue they didn¿t expect where the lead was attached to it and had difficulty.It was noted the patient developed keloids with the scar tissue and that was not determined until the first surgery/replacement was done.It was noted the scarring was significant and made lead replacement difficult to perform.No further complications were reported/anticipated.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7267689
• MDR Text Key: 99949602
• Report Number: 3004209178-2018-03223
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

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 Expiration Date: 11/28/2006
• 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: 01/31/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 02/22/2018
• Supplement Dates FDA Received: 03/13/2018
• Date Device Manufactured: 06/02/2005
• 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 Age: 32 YR