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

Model Number 3116

Device Problem Overheating of Device (1437)

Patient Problems Scar Tissue (2060); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: lead.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, 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

A caller reported a consumer had her implantable neurostimulator (ins) replaced and possible scaring of the lead end causing overheating over the ins.The caller noted the records unavailable for further assessment.Indication for use included gastric stimulation.

Manufacturer Narrative

"hcp reported that there was no other information available regarding the cause of the lead revision or any other issue that was written on the patient's chart" is not applicable to the event.

Event Description

Additional information from the rep reported the patient went in for a battery replacement because they had experienced a lack of therapy and that was all they did that day.The patient was also looking for other hcp's.

Event Description

Additional information from the hcp reported that there was no other information available regarding the cause of the lead revision or any other issue that was written on the patient's chart.The patient went in for a battery replacement because they had experienced a lack of therapy and that was all they did that day.The patient was also looking for other hcp's.

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; 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6211828
• MDR Text Key: 63472365
• Report Number: 3004209178-2016-27374
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2017

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: 05/28/2015
• 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: 12/07/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/11/2017
• Supplement Dates FDA Received: 01/31/2017; 01/31/2017; 09/28/2017
• Date Device Manufactured: 12/03/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 26 YR