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

Model Number 37800

Device Problem Bent (1059)

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

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id 4351-35 lot# serial# (b)(4) implanted: (b)(6) 2017 explanted: product type lead product id 4351-35 lot# serial# (b)(4) implanted: (b)(6) 2017 explanted: product type lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A manufacturing representative (rep) reported on behalf of a healthcare provider (hcp) that during implant both leads were placed and the hcp pulled the first lead out of the abdomen through the laparoscopic port.The metal tip was pulled through the port at a slight angle and once it came through it was noticed that the metal tip was bent.The hcp was able to insert it into the header block of the battery without issue.Impedance was normal at approximately 500.They completed the case without any additional issues.Each lead impedance was checked and both c<(>&<)>2 and c<(>&<)>3 were below 500.The rep noted that they were not sure which lead was bent.No further complications were reported/anticipated.

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): 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: 6600541
• MDR Text Key: 76276009
• Report Number: 3004209178-2017-11324
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2017
• 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: 05/04/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: 05/04/2017
• Supplement Dates FDA Received: 10/04/2017
• Date Device Manufactured: 02/18/2016
• 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 Age: 66 YR