MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION N'VISION; LEGGING, COMPRESSION, NON-INFLATABLE

Model Number 8840

Device Problem Human-Device Interface Problem (2949)

Patient Problem Urinary Tract Infection (2120)

Event Date 03/26/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8637-20, serial# (b)(4), implanted: (b)(6) 2010, product type: pump.(b)(4).

Event Description

Information received from a consumer patient who was receiving morphine (concentration and dose were unknown).Indication for use was noted as non-malignant pain and rsd (reflex sympathetic dystrophy)/causalgia-complex regional pain syndrome.It was reported that there was a change in therapy effect.The patient had withdrawal following a refill that occurred on (b)(6) 2015.The patient went to the emergency room (er) and later to the physician to have the programming corrected.The patient had symptoms of severe dehydration, urinary tract infection (uti) and vomiting foam.The symptoms occurred suddenly.The patient was dehydrated and treated for a uti in the er.It was stated that 2 weeks later the healthcare provider realized that the patient's symptoms were an issue on their part and brought the patient back in.The refill nurse had decreased the patient by 90%.Reason for this was misunderstanding in verbal orders from the healthcare provider regarding amount to decrease.The patient outcome and drug concentration/dose in the pump were unknown.Additional information has been requested, but was not available as of the date of this report.

Event Description

Additional information received from a healthcare provider (hcp).It was unknown what the programming issue was that occurred at the patient's refill.The patient had been seen by a manufacturer representative on (b)(6) 2015 but no communication was given to chart.The patient had not seen the physician since (b)(6) 2015.The hcp was unaware that the patient had a urinary tract infection (uti).They had not see the patient since the patient started going through withdrawals; the patient had cancelled their appointment with their physician in november.It was unknown if the patient was treated with antibiotics.It was also unknown if the patient was receiving effective therapy.

• Brand Name: N'VISION
• Type of Device: LEGGING, COMPRESSION, NON-INFLATABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 5293849
• MDR Text Key: 33409162
• Report Number: 3007566237-2015-03785
• Device Sequence Number: 1
• Product Code: LLK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• 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: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8840
• Device Catalogue Number: 8840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00054 YR