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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Nonstandard Device (1420)

Patient Problems Fall (1848); Muscle Weakness (1967); Overdose (1988)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal compounded baclofen 1000 mcg/ml at 153 mcg/day via an implantable pump.The indication for use was not reported.It was reported that there was a possible suspicion of over-infusion.As of (b)(6) 2018, the patient fell three times last week (muscle weakness).The patient was hospitalized.The hcp suspected over-infusion because he could not find anything else that might have caused this to happen.The pump was ¿twicely reduced with 10%¿.The daily dose was reduced from 153 mcg/day to 122 mcg/day.The patient was stable, and the patient's status was alive - no injury.However, it was unknown if the issue was resolved.It was noted that in weeks following the patient¿s last refill on (b)(6) 2018, nothing seemed wrong.The manufacturer representative asked the hcp for volume discrepancies, but the hcp said ¿volumes were too small to say anything about this¿.There were no applicable environmental, external or patient factors reported that might have led or contributed to the event.Diagnostics/troubleshooting indicated logs were clean.Surgical intervention did not occur and was not planned.The patient¿s medical history included an ambulatory stroke.The implant date was unknown.Patient weight and age were unavailable.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from a foreign healthcare professional (hcp) via a manufacturer representative.It was reported an 8840 clinician programmer was used to program the pump.It was noted that the hcp¿s measuring method was ¿not accurate enough¿ to determine if the pump was overinfusing more than 14.5% as they had 20 cc syringes.The neurologists had ruled out a new cardiovascular accident.The hcp wanted to report that it would be possible the pump overdosed.The hcp had no other explanation.When they refilled the pump, they made the most exact analysis of the residual volume (calculated/real).The hcp keep adjusting the pump (down) ¿whilst [the patient] was stable before¿.

• 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: 7742043
• MDR Text Key: 115784203
• Report Number: 3004209178-2018-17223
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 11/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1570-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention