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 Fall (1848); Granuloma (1876); Muscle Weakness (1967); Pain (1994); Complaint, Ill-Defined (2331); Numbness (2415)

Event Date 08/18/2018

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 8709, lot #: j10898r62, implanted: (b)(6) 2001, product type: catheter, ubd: 24-aug-2003, udi #: (b)(4).Product id: 8598a, serial #: (b)(4), implanted: (b)(6) 2011, product type: catheter, ubd: 06-apr-2013, udi #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving an unknown dose and concentration of morphine, clonidine, and another unknown drug via an implantable pump for non-malignant pain and chronic low back pain.It was noted the device was delivering a compound mixture.It was reported the patient was getting ready to have a magnetic resonance imaging procedure (mri) and was instructed by their healthcare provider to have a manufacturing representative (rep) check their pump after the mri.The mri was being done because the patient had a small granuloma at the tip of their catheter.The patient had previously had a computed tomography (ct) scan performed and now the neurosurgeon wanted to have an mri done.The patient stated they started having more symptoms in the past year and a ct scan noticed something small.The patient had a second ct scan six months later which identified the small granuloma at the tip of the catheter.The patient reported they had symptoms that were symptomatic of a granuloma.It was reported the granuloma was identified at some point in the past year, in 2018.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 was received from a healthcare professional (hcp) via manufacturer representative (rep).It was reported that the rep was going into a case to remove the granuloma.Mass was surgically removed.The granuloma was excised and the catheter tip was trimmed off; the hcp elected to remove the tip of the catheter.Morphine dose was 9mg/day and they lowered it to 6 mg/day.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the company representative (rep).The rep reported a magnetic resonance imaging procedure (mri) was performed on (b)(6) (2019).They were waiting for the neurosurgeon to read the report and determine the next step.The pump and catheter were still active and functioning in the patient.The rep indicated that if the devices were explanted they would return them.The information provided had been confirmed with the physician/account.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient via a company representative who reported that the patient¿s symptoms also included numbness and frequent falls.The issue was not resolved at the time of this report.It was unknown if surgical intervention was planned.The patient status at the time of this report was reported as ¿alive ¿ no injury¿.No further complications have been reported as a result of this event.

Manufacturer Narrative

Patient code (b)(4) is no longer applicable.The codes applied in method/result/conclusion, are only applicable for product id: 8709 lot# j10898r62; product type, catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider (hcp).It was reported the patient had experienced weakness and pain in their legs associated with the granuloma.The granuloma was associated with catheter model number 8709, lot number j10898r62.There were no known factors that may have caused or contributed to the formation of the granuloma.The granuloma was diagnosed six months earlier, relative to (b)(6) 2019.Regarding further actions/interventions taken or planned, the doctor was awaiting the neurosurgeon's decision.

Manufacturer Narrative

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

Event Description

Additional information was received via a company representative.The explanted catheter component was discarded by the healthcare provider and therefore would not be returned to the manufacturer.

• 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: 8344766
• MDR Text Key: 136316608
• Report Number: 3004209178-2019-03334
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Date Device Manufactured: 03/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1151-2008
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 72