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

Model Number 8637-40

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Overdose (1988); Pain (1994); Increased Sensitivity (2065); Burning Sensation (2146); Numbness (2415)

Event Date 02/12/2018

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 via a clinical study regarding a patient receiving dilaudid (4.0 mg/ml at 3.1548 mg/day), bupivacaine (30.0 mg/ml at 23.661 mg/day), compounded baclofen (200.0 mcg/ml at 157.74 mcg/day), and clonidine (200.0 mcg/ml at 157.74 mcg/day) via an implanted pump.The indication for use was spinal pain.It was reported the patient had shortness of breath and increased pain on (b)(6) 2018.The clinical diagnosis was it medication side effects.The patient presented to the emergency department with lower extremity numbness on (b)(6) 2018.The next day therapy was suspended via magnet while in the hospital at 00:10.Later that afternoon, the patient reported burning pain had improved.The healthcare provider attributed this to either hyperalgesia or over-medication of bupivacaine.Therapy was resumed and daily rate was decreased 50%.On (b)(6) 2018, the patient had upper extremity numbness.The patient was examined, on (b)(6) 2018, and revealed increased radicular numbness.The patient's it rate was decreased by 33% and discussed catheter revision.The next day the patient had increased tingling following ptm activations.On (b)(6) 2018, the patient had uncontrolled pain secondary to it rate decreases due to side effects.The it rate was decreased again and started extended release morphine.On (b)(6) 2018, the pain had improved and side effects had resolved.The patient declined catheter revision.It was indicated the event was related to the device or therapy and related to the drugs hydromorphone, bupivacaine, clonidine, and baclofen.The event resulted in in-patient hospitalization.The issue resolved without sequelae on (b)(6) 2018.Additional information reported the hospitalization was a result of the reported event.The ca use of the burning pain was unknown.The patient's baseline weight was (b)(6).

Manufacturer Narrative

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

• 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: 7671768
• MDR Text Key: 113503670
• Report Number: 3004209178-2018-15342
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• 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: 08/08/2018
• Date Device Manufactured: 06/06/2017
• 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): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 99