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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Aspiration Issue (2883); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Muscular Rigidity (1968); Tachycardia (2095); Therapeutic Response, Decreased (2271)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

The main device.Other components include: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2011, product type: catheter.Product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2011, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving 2000 mcg/ml of baclofen at 40 mcg/day via an implantable pump via an implantable pump for intractable spasticity and cerebral palsy.On (b)(6) 2017, it was reported that the patient had a return of symptoms shortly after their pump replacement.A dye study was attempted and the hcp reported that it was difficult to aspirate or inject from the catheter.The patient's pump was replaced on (b)(6) 2017 and by 0400 on (b)(6) 2017, the patient was having symptoms including spasticity, itchiness, elevated temperature, hypertension, hypotension, and tachycardia.The patient was given versed and cyproheptadine to help manage the withdrawal symptoms.The hcp reportedly tried to aspirate from the catheter and it was very difficult and even more difficult to inject.The hcp noted that they thought they saw some contrast by the pump connector, but stated that it was difficult to see.No further complications were reported.

Manufacturer Narrative

Updated to reflect the information received on 2017-dec-19 (b)(4) added to reflect the information received on 2017-dec-19.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient's healthcare provider (hcp) via a manufacturer's representative (rep) on 2017-dec-19.It was reported that, when they could not aspirate well from the catheter access port (cap), the catheter was disconnected and they got free csf flow.The port was flushed and a "tiny bit of tissue" seemed to be dislodged.After connection was made again, 2 cc's were aspirated without problems.The issue was considered resolved at the time of the report.

Manufacturer Narrative

Updated to reflect the patient's weight provided on 2018-jan-04.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient's healthcare provider (hcp) on 2017-jan-04.The patient's weight was provided.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer's representative on 2017-dec-15.It was reported that the patient had withdrawal symptoms since the pump exchange last week/2017 (b)(6).It was noted that there was a possible connection issue as a environmental/external/patient factors that may have led or contributed to the issue that may have led or contributed to the issue.A computerized tomography (ct) scan and dye study were performed and the hcp thought they saw some dye around the pocket.They were going to explore the pocket on 2017 (b)(6) as surgical intervention to resolve the issue.It was reported that lioresal was in the pump.At the time of the report the issue was not resolved and the patient status was ¿alive ¿ no injury¿ (note this is conflicting with the report of withdrawal symptoms).The patient¿s medical history included cerebral palsy.Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer.No further complications were reported or anticipated.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7123699
• MDR Text Key: 95768133
• Report Number: 3004209178-2017-26128
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Date Device Manufactured: 12/04/2017
• 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
• Patient Age: 18 YR
• Patient Weight: 46