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 Fatigue (1849); Fever (1858); Low Blood Pressure/ Hypotension (1914); Overdose (1988); Chills (2191); Complaint, Ill-Defined (2331); Low Oxygen Saturation (2477)

Event Date 01/19/2020

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) via a manufacturer's representative (rep) regarding a patient who was receiving 1500 mcg/ml of baclofen at 419 mcg/day, 12,000 mcg/ml of dilaudid at 3356 mcg/day, and 9.0 mcg/ml of prialt at 2.5166 mcg/day via an implantable pump for intractable spasticity.On (b)(6) 2020, it was reported that the patient was "out of it", drowsy, their o2 level was low, their blood pressure was low, and they had chills and a fever which went away.The patient had a fentanyl patch on approximately 3 week prior to the date of the event and had the same symptoms.The patch was removed and the symptoms went away.Similar symptoms came back on (b)(6) 2020 in the absence of the fentanyl patch.The patient's pump was interrogated and was confirmed to be working.The patient's pump infusion was decreased by 20% and the patient's personal therapy management programmer (ptm) was disabled.The patient was also given and naloxone drip.The issue was not considered resolved at the time of the report.No surgical intervention had occurred or was planned.The patient's status was listed as "alive-no injury".No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare provider (hcp) via a manufacturer's representative (rep) reported the exact cause of the patient¿s symptoms were not determined.The physicians in the er speculated that the patient was having overdose type symptoms to his meds in the pump but were not sure why.As of yesterday the symptoms the patient originally came to the er for have been resolved, but the physicians assistant who was treating the patient that day said that the patient had complained of generalized pain.The pa said it was probably due to the fact that the base rate of the pump was lowered therefore he was getting less pain meds from the pump.They were treating with iv pain meds until the patient was able to give themselves a bolus via the ptm which was re-activated.

• 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: 9700555
• MDR Text Key: 185767969
• Report Number: 3004209178-2020-03185
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

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: 08/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 02/14/2020
• Date Device Manufactured: 02/18/2016
• 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: 62 YR
• Patient Weight: 108