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

Model Number 37800

Device Problems Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Undesired Nerve Stimulation (1980); Tingling (2171); Electric Shock (2554)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.

Event Description

The consumer reported that the patient had shocking at the leads and implantable neurostimulator (ins) locations since (b)(6) 2016.The shocking was where the machine was and it got worse when eating something and the patient could feel it sending tingles and ended with shocks.The patient had shocks usually first and then tingles.The patient had no trauma or falls.The patient was pregnant and had a baby (b)(6) ago and was not sure if this had any effect on the location of the wiring.On (b)(6) 2016 the shocking was continuous and it sometimes was on one side and moved to the other side.The indication for use for this patient was gastric stimulation.

Event Description

Additional information received from the consumer reported that the patient had notified their managing health care provider (hcp) about the shocking and the appointment date was (b)(6) 2016.The patient was not sure of the circumstances that led to the shocking and it happened after the patient ate certain things.The patient was waiting on steps to resolve the shocking.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5627237
• MDR Text Key: 44387150
• Report Number: 3004209178-2016-08703
• 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,Followup
• Report Date: 06/01/2016

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: 01/28/2016
• 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: 04/11/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided; 05/09/2016
• Supplement Dates FDA Received: 06/01/2016; 09/21/2017
• Date Device Manufactured: 08/12/2014
• 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: 28 YR