MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seizures (2063); Loss of consciousness (2418)

Event Type  Injury  

Event Description

It was reported that three years prior to the report the patient began having seizures.She was put on 20 plus prescriptions and thought the med mixtures or problems may be causing the seizures.She stopped all meds except psych and had no seizures in four weeks and was regaining her memories.The patient mentioned ¿previous blackout for three years.¿ she also mentioned being in the hospital in december where the doctors gave her morphine for two hours and did not give her any other meds because ¿another doctor said her seizure levels were low, but that doctor told others to give her dilaudid, but they never did.¿ it was unclear if the seizures were related and no interventions or patient outcome were reported, so additional information was requested.If additional information is received a supplemental report will be sent.

Manufacturer Narrative

Concomitant products: product id 435135, serial # (b)(4), implanted: (b)(6) 2009, product type lead; product id 435135, serial # (b)(4), implanted: (b)(6) 2009, product type lead; product id neu_ptm_prog, lot # unknown, product type programmer, patient.(b)(4).

Event Description

Additional information received from healthcare provider reports, the patient had not been seen in clinic in several months and not at the time of the seizures.She was evaluated by her neurologist.It was reported that the patient recovered without permanent impairment.It was noted by the healthcare provider, they did not feel the device "related seizures".

Manufacturer Narrative

(b)(4).

Event Description

No additional information regarding device (restated patient outcome, seizures unrelated to device, etc).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 4490059
• MDR Text Key: 5330605
• Report Number: 3004209178-2015-01892
• 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,Followup
• Report Date: 01/15/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2010
• 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: 06/05/2015
• Initial Date FDA Received: 02/06/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/06/2015; 06/05/2015
• Date Device Manufactured: 11/15/2008
• 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): Other
• Patient Age: 00039 YR