MAUDE Adverse Event Report: MPRI ENTERRA; INTESTINAL STIMULATOR

Model Number	4351-35
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported during the procedure the proline suture on the lead snapped during the placement.The rep noted the hcp removed it and opened another lead and placed it successfully.The rep noted they were unable to determine the return status, they thought it was thrown away.The rep noted it was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.The rep stated it was unknown if there was any diagnostics or troubleshooting performed.The rep noted the actions taken to resolve the lead snapping was a new lead was placed and the issue was resolved at the time of the report.The patient was listed as alive with no injury at the time of the report.There were no further complications that have been reported as a result of this event.

• Brand Name: ENTERRA
• Common Device Name: INTESTINAL STIMULATOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8298186
• Report Number: 2649622-2019-01787
• Device Sequence Number: 19330654
• Product Code: LNQ
• UDI-Device Identifier: 00643169936577
• UDI-Public: 00643169936577
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: H990014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2020
• Device Model Number: 4351-35
• Device Catalogue Number: 4351-35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR