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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976); Unintended Movement (3026)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the healthcare provider (hcp) regarding a patient who had been receiving bupivacaine, hydromorphone, and fentanyl via an implantable pump for non-malignant pain and post lumbar laminectomy syndrome. The hcp indicated they had not seen the patient since (b)(6) 2017. The patient¿s pump was last filled with medication on (b)(6) 2015. The drug was not replaced with saline. The patient was scheduled to see the doctor on (b)(6) 2018 to discuss and schedule a pump explant. It was indicated the device would be returned to the manufacturer for analysis. The following information was provided by the healthcare provider via the pump logs and chart notes. The patient was seen on (b)(6) 2015 for a pump refill. The patient stated that her pump had been moving more than it had in the past. The patient had a history of the pump being significantly tilted but was more so even now (relative to the day of the report, (b)(6) 2015). The pump was noted as being extremely tilted and a quarter rotated with minimal tenderness. The physician was able to rotate the pump in order to obtain access to the refill port with minimal difficulty. The patient was otherwise currently in good health. The pump was refilled with 7. 5 mg/ml of bupivacaine, 1. 5 mg/ml of hydromorphone, and 375 mcg/ml of fentanyl. The device was interrogated and the correct concentration and volume were confirmed along with the expected residual volume of 8. 3 milliliters (mls). No complications were noted. The device was interrogated and found to be in ¿pump in safe state¿ which occurred the day before, (b)(6) 2015 at 11:46 a. M. (please see mfr report # 3004209178-2015-18636). The elective replacement indicator (eri) was currently at 30 months. The pump was refilled and programmed to deliver an increased concentration of fentanyl and decreased concentration of hydromorphone and bupivacaine. On (b)(6) 2015 the patient was seen for a routine consideration for resumption of intrathecal infusion therapy. The hcp discussed the possibility of replacing the patient¿s pump and also possibly replacing the catheter (please see mfr report # 3004209178-2018-15637). The patient¿s past medical history included coronary artery disease, peripheral neuropathy, cardiac arrhythmia, anemia, hyperlipidemia, neuropathy, hypertension, esophageal reflux, constipation, osteoarthritis, allergic rhinitis, and myocardial infraction. The patient had a stent placed in their left anterior descending artery (b)(6) 2011, a lumbar spinal fusion 2002, and a cholecystectomy. Allergies included codeine and baclofen. On (b)(6) 2016 the patient had an exam for a follow-up on her medication and pre-evaluation prior to having her intrathecal pump exchanged and catheter revised. The patient was not prepared for their upcoming pump replacement, which was scheduled for (b)(6) 2016. The patient requested to have the procedure moved out a month. The patient was managing with oral morphine. It was indicated the pump replacement and catheter replacement would be postponed until (b)(6) 2016. On (b)(6) 2016 the patient had a follow-up appointment for her medication regarding management for her chronic lumbar pain secondary to degenerative disc disease, post laminectomy syndrome, as well as a pre-evaluation for her intrathecal pump and catheter replacement. The patient had not been cleared by her family practice doctor. The patient was to continue with morphine for breakthrough pain and follow-up with her cardiologist. Once cleared, the plan was to proceed with the pump replacement and catheter revision. On (b)(6) 2016 the patient was seen for a follow-up appointment for her medication regarding management for her chronic lumbar pain and radiculopathy secondary to post-laminectomy syndrome and degenerative disc disease. The patient was debating whether or not to have the pump replaced, versus explanted. The patient¿s oral medications were adjusted, with instructions to follow-up in one month for re-evaluation. On (b)(6) 2016 the patient was seen for a follow-up on medication management for chronic lumbar pain with lumbar radiculopathy secondary to post-laminectomy syndrome and degenerative disc disease. The patient did not wish to pursue any replacement of her pump. No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) on (b)(6) 2018 indicated the cause of the pump extremely tilted and rotated/pump movement was unknown. It was noted that the pump movement began sometime in 2015. No actions/interventions were noted in the patient's chart besides manipulation. The pump and catheter status were noted to be off/safe mode and has not been in use since 2015. No further complications were reported.

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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7683022
• MDR Text Key: 113867000
• Report Number: 3004209178-2018-15641
• Device Sequence Number: 1
• Product Code: LKK
• 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

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/27/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/12/2018 Patient Sequence Number: 1