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 Low Blood Pressure/ Hypotension (1914); Seizures (2063); Dizziness (2194); Numbness (2415); Loss of consciousness (2418)

Event Date 06/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.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 clinical study regarding a patient receiving bupivacaine (30.0 mg/ml at 13.503 mg/day), clonidine (300.0 mcg/ml at 135.03 mcg/day), and morphine (5.0 mg/ml at 2.2505 mg/day) via an implantable infusion pump.The indication for use was noted as non-malignant pain.It was reported the patient had lightheadedness, low blood pressure, and upper extremity and abdominal numbness following ptm activations on (b)(6) 2017.The clinical diagnosis was it medication side effects following ptm activations and it medication side effects with or without side effects.The pump was reprogrammed and the continuous rate was decreased.On (b)(6) 2017, the patient reported feeling lightheaded following ptm activations and requested a change to the concentration of medications.The patient was refilled with a new concentration of medications and opioid was rotated to allow for decreased clonidine and bupivacaine on (b)(6) 2017.It was noted the patient's pump was interrogated on (b)(6) 2017and reported episode of convulsions and when paramedics arrived the patient had low blood pressure.The patient stopped utilizing the ptm, as they were fearful the issue may reoccur.The next day, the patient reported increased black out episodes and the pump was refilled without clonidine.It was indicated the event was related to the device or therapy and related to the drug bupivacaine/clonidine and the drug action being increase dose.The issue resolved without sequelae on (b)(6) 2017.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) via a clinical study.It was reported that the patient¿s baseline weight was (b)(6) lbs.When asked the cause of the seizure and blackout, it was reported that the site indicated there was an increase on intrathecal clonidine.It was reported that there was no mention of overdose and no mention of a device issue.It was previously reported that the clinical diagnosis was it medication side effects with and without side effects.New information reports the clinical diagnosis as it medication side effects with and without ptm activations.No further complications were reported and/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: 6962892
• MDR Text Key: 89776605
• Report Number: 3004209178-2017-22169
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2017
• Date Device Manufactured: 09/15/2015
• 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 Age: 31 YR
• Patient Weight: 91