MAUDE Adverse Event Report: MPRI ENTERRA; INTESTINAL STIMULATOR

Model Number	4351-35
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the distal end of the lead was stretched.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 manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported there was a bent ski needle that was noticed in the lead packaging.The rep noted that visual determination determined the defeat.It was noted the needle would be returned.It was noted the issue was resolved 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: 8277633
• Report Number: 2649622-2019-01339
• Device Sequence Number: 1500452
• Product Code: LNQ
• UDI-Device Identifier: 00643169936577
• UDI-Public: 00643169936577
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/25/2019

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: 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: 11/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1