MAUDE Adverse Event Report: MPRI ENTERRA; INTESTINAL STIMULATOR

Model Number 4351-35

Device Problems Peeled/Delaminated (1454); Shipping Damage or Problem (1570)

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

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was being implanted with a neurostimulator for gastric stimulation.It was reported that the blue prolene separated on the lead.The lead was never implanted and a new lead was used.This issue was noted to be resolved.No symptoms or further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) via a manufacturer representative (rep).It was reported that they were unsure of the cause of the prolene separating.The surgeon believed it was a manufacturing issue.

Manufacturer Narrative

Analysis results were not available at the time of this report.An additional report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the lead (b)(4) found that the lead was broken at the distal end.The device was subjected to a series of standard tests, including visual inspection and electrical testing.It was found that the hole drilled for the polypropylene suture was off center and out of specification.If information is provided in the future, a supplemental report will be issued.

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): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7934392
• MDR Text Key: 122812627
• Report Number: 2649622-2018-16199
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169936577
• UDI-Public: 00643169936577
• 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,Followup,Followup,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2020
• Device Model Number: 4351-35
• Device Catalogue Number: 4351-35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2018
• 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 Age: 47 YR