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

Model Number 3116

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Eructate (1839); Muscle Spasm(s) (1966); Pain (1994); Paresis (1998); Vomiting (2144); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that the patient had been burping and throwing up and had some bile.The patient stated they had been throwing up since they left the hospital two days prior to report and that their symptoms were following an implant.The patient stated they felt a big bolt and had a spasm and ¿thinks it in her whirlwind.¿ the patient¿s family thought it was the patient¿s gastroparesis.It was noted that the patient was back in the hospital at the time of report because of their symptoms of gastroparesis, burping, and throwing up bile.It was noted that the patient¿s healthcare provider felt it was the patient¿s gastroparesis.Later that day, it was reported that the patient was admitted to the hospital with vomiting and their device was implanted the day prior to report.It was noted that the vomiting had been going on for more than 24 hours.Nine days later, the patient the patient stated they had pain since that morning where they had their staples for the implant.The patient was scheduled to have their staples removed three days later.The patient also reported a pulling sensation and a short burst of pain, like the area was contracting.The patient stated they had been belching all day.It was later reported by a healthcare provider that the cause of the event was not determined and there was no troubleshooting or interventions taken.The healthcare provider did not know the patient¿s outcome was not aware of the ¿reported event.¿ no interventions or outcome were reported related to this event.Additional follow up is being conducted to obtain this information.If additional information becomes available, a supplemental report will be sent.

Manufacturer Narrative

Concomitant 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.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received more than a year later reported that the patient's low back was killing her and she had degenerative discs.The patient reported that they thought she had "micro-opathy" and her muscles were going away because she was malnourished and losing weight because of her gastroparesis, which she had prior to get the device.The patient did not know when this started to occur, maybe 4 months ago or more.

• 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: 4542273
• MDR Text Key: 21450350
• Report Number: 3004209178-2015-03601
• 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,consumer,health profess
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2015

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: 05/28/2016
• 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: 01/30/2015
• Initial Date FDA Received: 02/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2016
• Date Device Manufactured: 12/13/2014
• 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): Hospitalization
• Patient Age: 00053 YR