MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number NEU_UNKNOWN_PUMP

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

Patient Problems Dyspnea (1816); Muscular Rigidity (1968); Overdose (1988); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from (b)(6) regarding a patient receiving unknown drug via an implanted pump.It was reported after the patient was having a bit of a nightmare with the baclofen pump.It was noted the pump was increased by another 5% about seven to eight weeks before report date and it became too much.The patient's breathing was affected and their lean to the right was more difficult to correct.By the time the patient managed to get an appointment the breathing had settled down but the spasticity was bad.The patient went to see their healthcare provider three weeks prior to this report and they reduced the pump by 2.5%.It was also noted the patient was getting really sharp pain in the back of their legs and especially at night when the patient needs two pillows to keep their knees bent and their heels off the bed.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7441202
• MDR Text Key: 105844836
• Report Number: 3007566237-2018-01138
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_PUMP
• Device Catalogue Number: NEU_UNKNOWN_PUMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2018
• 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