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

Model Number 8637-20

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

Patient Problems Fall (1848); Overdose (1988); Numbness (2415); Ambulation Difficulties (2544)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) and from a consumer via a manufacturer's representative (rep) regarding a patient who was receiving 15 mg/ml of fentanyl at 1.793 mg/day, 4 mg/ml of marcaine at 0.4782 mg/day, and 1.1 mg/ml of ketamine at 0.1315 mg/day via an implantable pump for other chronic/intractable pain (trunk/limbs) and spinal pain.On (b)(6) 2018, it was reported that the patient had an overdose.The patient reported that they fell on the morning of (b)(6) 2018 and was seen in the er.The patient stated that their feet were numb and they lost their balance.According to the patient, their feet frequently go numb and cause them to fall.At the er, the hcp reported that the patient was showing signs of overdose.A rep interrogated the patient's pump and found that it was working normally.No actions/interventions were taken to resolve the issue.No surgical intervention had occurred nor was a surgical intervention planned.The issue was considered resolved at the time of the report.No further complications were reported.The patient¿s medical history included seizure, high blood pressure, and chronic pain.

• 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: 7837935
• MDR Text Key: 118926284
• Report Number: 3004209178-2018-19684
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 08/31/2018
• Date Device Manufactured: 11/05/2015
• 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): Other
• Patient Age: 63 YR