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

Model Number 3116

Device Problems No Device Output (1435); Malposition of Device (2616); Electromagnetic Compatibility Problem (2927)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported that a patient¿s symptoms weren¿t being controlled with her gastric implantable neurostimulator (ins), it was no good, and she got side effects every time she turned it on.The patient¿s doctor tried to start it out very slowly, it was only up 5, and there was ¿no way¿ the patient would get a side effect from it.She didn¿t know how long it was on or off, but she got a side effect and her doctor said that she wasn¿t getting the side effect from the ins.The patient also had an implantable neurostimulator (ins) for deep brain stimulation and was having some problems so she had to have both devices turned off.Both devices had to be placed in the patient¿s abdomen because she was so thin.She didn¿t think the ins's were 8 inches apart and they were closer together than that.The deep brain stimulation system had been turned off, but somehow with getting the gastric device put in, the deep brain stimulation system was turned on and the patient got those symptoms back.The event had occurred a couple of weeks prior to the report.The patient¿s doctor told her that the deep brain stimulation system was turned on internally somehow and had been turned on for 86 hours.The patient knew she didn¿t turn it on.She thought she was going to get the deep brain stimulation device taken out.She had to have the gastric device otherwise she couldn¿t eat, and she needed to have the gastric device turned on.The patient couldn¿t turn the gastric device back on right now while the deep brain stimulation device was still implanted.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain additional information.If additional information is received, a follow-up report will be sent.See mfr.Report 3004209178-2012-11218 for information regarding the patient¿s deep brain stimulation device system.

Manufacturer Narrative

Concomitant 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).

Event Description

Additional information received reported that the patient's deep brain stimulation (dbs) implantable neurostimulator (ins) was placed in the abdominal area and when she received the gastric ins, it was determined the inss were anatomically closer than recommended to each other to avoid interference, on either side of the linea alba, below the umbilicus.It was suggested by her that her adjacent gastric ins was activating her dbs ins and the dbs ins would turn on intermittently.The dbs ins was removed on (b)(6) 2015 and leads were left implanted.The patient recovered without permanent impairment.

• 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: 4524856
• MDR Text Key: 5492002
• Report Number: 3004209178-2015-03231
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2015

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: 01/14/2016
• 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: 04/23/2015
• Initial Date FDA Received: 02/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2015
• Date Device Manufactured: 07/17/2014
• 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 Outcome(s): Required Intervention