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

Model Number 3116

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problem Tingling (2171)

Event Date 05/31/2014

Event Type  malfunction  

Event Description

It was reported the patient¿s newly implanted neurostimulator seemed to be causing their insulin pump sensors to error out.It was stated they were wondering if they should use the sensors because they were feeling a tingling sensation at the implant site.It was noted the patient would get the tingling sensation when they use the insulin sensors and the issue began when they first got home following the implant.It was reported the patient had gone through 5 sensors because they kept getting errors and one sensor would usually last them 6 days.

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type: lead; product id 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

Manufacturer Narrative

Pma # was corrected to h990014.The previous pma # was incorrect.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3896818
• MDR Text Key: 4673135
• Report Number: 3004209178-2014-12079
• Device Sequence Number: 1
• Product Code: LNQ
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/04/2014

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: 09/14/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 06/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2014
• Date Device Manufactured: 03/19/2014
• 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: 00052 YR