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

Model Number NEU_UNKNOWN_PUMP

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cognitive Changes (2551)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, serial# unknown, product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from saol therapeutics regarding a patient receiving lioresal at a dose of 1100 mcg/day via an implanted pump.It was reported the patient was obtunded.It was noted that last evening ((b)(6) 2019), when replacing the lioresal pump it was noted the catheter was in the posterior soft tissue and not in the spinal canal.The healthcare provider was wondering if this was due to getting too much or too little drug.The patient's catheter was replaced intrathecally and the doe was dropped to 600 mcg/day.On (b)(6) 2019, the patient was obtunded.The patient's vital signs were normal, temperature was normal, blood pressure was a little lower than the night before but everything was fine.It was also noted the patient responded to the pain.The pump was turned down to minimal rate and the patient was sent to have an imaging study of the head because the original diagnosis was due to stroke and cerebral vascular disease.

• 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: 8386711
• MDR Text Key: 137703067
• Report Number: 3007566237-2019-00517
• Device Sequence Number: 1
• Product Code: LKK
• 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: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_PUMP
• Device Catalogue Number: NEU_UNKNOWN_PUMP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• 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