MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

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

Patient Problems Itching Sensation (1943); Muscular Rigidity (1968); Pain (1994); Paralysis (1997); Swelling (2091); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Test Result (2695)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter. (b)(4).

Event Description

On (b)(6) 2015, additional information was received from a physician via (b)(4), regarding a patient who was receiving baclofen (500 mcg/ml) at 84. 95 mcg/day via an implantable pump in simple continuous mode. It was noted that the pump settings had been examined on (b)(6) 2015 at 14:23, and had not been changed since (b)(6) 2015 at 15:14. On (b)(6) 2015 at 14:25, the pump was reprogrammed to deliver baclofen (2000 mcg/ml) at 115 mcg/day via simple continuous infusion, a daily dose increase of 35%. A bridge bolus of 0. 391 ml was programmed.

Event Description

It was reported that the patient experienced baclofen withdrawal. Lab work was done on (b)(6) 2015 which found that the patient had a urinary tract infection (uti). On (b)(6) 2015, an abdominal computed tomography (ct) scan found normal pump and catheter placement. On (b)(6) 2015, additional lab work was done which found that the patient had decreased hemoglobin levels and an increased cardiac index. The patient was reprogrammed to receive a 50 mcg bolus. Lab work was done on (b)(6) 2015 which found that the patient still had a urinary tract infection (uti). An echocardiogram (eeg) was done on (b)(6) 2015 which showed abnormal results consistent with mild, nonspecific/generalized cerebral dysfunction. No seizure or epileptiform discharges seen. Lab work done on (b)(6) 2015 found that the patient had an elevated platelet count. The etiology was listed as a worsening or exacerbation of a pre-existing condition. The event was possibly related to the device or therapy but unlikely related to the implant procedure. The signs and symptoms included increased spasticity, increased tone in bilateral lower extremities, occasional itching, full body paralysis, and swelling and pain in bilateral legs and heels of feet. The event resulted in in-patient or prolonged hospitalization. The event had resolved without sequela on (b)(6) 2015. A follow-up report will be submitted if more information becomes available.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• 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: 4946256
• MDR Text Key: 13969299
• Report Number: 3004209178-2015-14177
• 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: Study,Health Professional,health professional,stu

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/28/2015 Patient Sequence Number: 1