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

Model Number 37800

Device Problems High impedance (1291); Migration or Expulsion of Device (1395)

Patient Problems Nausea (1970); Twiddlers Syndrome (2114); Hernia (2240); Abdominal Distention (2601)

Event Date 02/01/2017

Event Type  malfunction  

Event Description

The patient¿s healthcare provider reported that the patient experienced nausea once a day, bloating and a possible hernia.Vomiting was currently not an issue.The change in the patient¿s therapy/symptoms was gradual.Impedance values were check which resulted in elevated impedance values; c2=6042, c3=1535, 2<(>&<)>3= 8,000 (range).It was noted that the patient¿s previous readings were about 300 ohms.It was also reported that he patient¿s ins was loose in their pocket.It was noted that it was possible that the patient experienced twiddler¿s syndrome, the patient ¿had some psych issues.¿ the patient¿s healthcare provider wanted to complete a ct scan to rule out the hernia and egd for the lead placement.No further complications were reported/anticipated.

Manufacturer Narrative

Corrected information: sex, date of birth.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: 6590738
• MDR Text Key: 75971835
• Report Number: 3004209178-2017-11037
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

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: 11/28/2017
• 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: 05/22/2017
• Initial Date FDA Received: 05/25/2017
• Supplement Dates Manufacturer Received: 05/22/2017
• Supplement Dates FDA Received: 10/04/2017
• Date Device Manufactured: 06/01/2016
• 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: 45 YR