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

Model Number 37800

Device Problems Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2015

Event Type  Injury  

Event Description

It was reported that the patient had impedance issues post-operative.Upon returning to the or (operating room) and opening the pocket, one loosened and tightened again, the impedance was within normal range.Healthcare provider was concerned that there may be an issue with whether the torch wrench was tightening the pins sufficiently in the pocket.Additional information has been requested but was not available as of the date of this report.A follow-up report will be made if additional information becomes available.

Manufacturer Narrative

Concomitant products: product id neu_unknown_lead, serial # unknown, product type lead; product id neu_wrench_acc, serial # unknown, product type accessory.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported baseline symptoms of nausea/vomiting, and no other significant symptoms.The impedance measurement were program c and 2 >20000 and c and 3 302, 2 and 3 >20000.It was reported that the patient was going to the operating room on (b)(6) 2015.

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 a patient with an implantable neurostimulator (ins) had a pocket revision on (b)(6) 2015.There was no generator changes.No further complications were reported/anticipated.

Event Description

Additional information received reported that a field engineer went with the manufacturer representative 3 days ago to get information on the issue and understand it.

• 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 MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 4789211
• MDR Text Key: 5877562
• Report Number: 3007566237-2015-01392
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/20/2017

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: 07/28/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/18/2017
• Supplement Dates FDA Received: 06/26/2015; 06/26/2015; 09/20/2017
• Date Device Manufactured: 02/04/2015
• 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