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

Model Number 37800

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 435135, serial# (b)(4), implanted: (b)(6) 2009, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2009, product type: lead.

Event Description

A manufacturing representative (rep) reported on behalf of a healthcare provider (hcp that the patient's symptoms returned.It was unknown if the patient had any dehydration or vomiting.They were still experiencing shocking and impedance was out of range.C2 was at 417 ohms, c3 was at 709 ohms and 2/3 at 1160 ohms on their 30/day check up.They needed to be within 200-800.Multiple impedance checks were done and x-ray was negative.The next step was to do a full lead revision.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information from the manufacturing representative (rep) reported that a revision was completed on (b)(6)2017.No further complications were reported/anticipated.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6699029
• MDR Text Key: 79647991
• Report Number: 3004209178-2017-14519
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

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: 03/14/2018
• 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: 07/06/2017
• Initial Date FDA Received: 07/10/2017
• Supplement Dates Manufacturer Received: 08/01/2017
• Supplement Dates FDA Received: 08/15/2017
• Date Device Manufactured: 09/14/2016
• 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
• Patient Age: 40 YR