MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problem High impedance (1291)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

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 manufacturing representative (rep) reported on behalf of a healthcare provider (hcp) that a patient showed up in the office with an increase in symptoms on (b)(6) 2017.The hcp found an impedance issue that was out of range > 800.They admitted the patient to the hospital and did a revision on (b)(6) 2017.They tightened the set screws and lowered the impedance within the normal range.The issue was with lead 3 as c <(>&<)> 3 were out of range.The patient woke up out of surgery and had immediate relief of their symptoms.No further complications are anticipated.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 6421116
• MDR Text Key: 70459424
• Report Number: 3004209178-2017-06023
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

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: 09/14/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: 02/23/2017
• Supplement Dates FDA Received: 10/02/2017
• Date Device Manufactured: 03/21/2016
• 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