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

Model Number 8637-40

Device Problems Insufficient Flow or Under Infusion (2182); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Headache (1880); Vomiting (2144); Discomfort (2330); Malaise (2359); Alteration in Body Temperature (4568); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/12/2021

Event Type  malfunction  

Event Description

Information was received from a consumer regarding a patient receiving morphine via an implantable pump.The indication for use was spinal pain.The patient¿s family member reported that they believed the pump has not been working correctly.Per the reporter about a week and a half ago, they had to take the patient to the er (emergency room) due to severe vomiting, diarrhea, very bad headaches, was freezing, patient kept yawning, was aching all over like they had the flu, and had bad abdominal pain.The healthcare provider at the er (emergency room) did a cat scan on the patient¿s stomach, but didn't find anything.Per the reporter, it started around the (b)(6).The reporter stated they tried contacting the healthcare provider¿s office, but were unable to get in touch with the patient¿s nurse that fills the pump.They were directed by the healthcare provider¿s office to contact the manufacturer and inquired if the pump could be checked remotely.The reporter noted that when the issues occurred, they didn't think of the pump then, and stated the patient might have had covid or food poisoning.The reporter was redirected to their healthcare provider to further address the issue.Additional information was received from the healthcare provider (hcp) indicated that at the time of refill the expected reservoir volume was 9 and the action reservoir volume was 30.A catheter dye study was performed and no flow was confirmed.A mri of the catheter was negative for any granulomas.The hcp suspected scar tissue or catheter obstruction; the cause was unknown.The patient was being weaned down and provided oral medication.

Manufacturer Narrative

Concomitant medical products: product id: 8709sc; product type: catheter.Product id: 8578; product type: catheter.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: product id: 8709sc; product type: catheter.Product id: 8578; product type: catheter.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 morphine via an implantable pump.The indication for use was spinal pain.The patient¿s family member reported that they believed the pump has not been working correctly.Per the reporter about a week and a half ago, they had to take the patient to the er (emergency room) due to severe vomiting, diarrhea, very bad headaches, was freezing, patient kept yawning, was aching all over like they had the flu, and had bad abdominal pain.The healthcare provider at the er (emergency room) did a cat scan on the patient¿s stomach, but didn't find anything.Per the reporter, it started around the 12th of november the reporter stated they tried contacting the healthcare provider¿s office, but were unable to get in touch with the patient¿s nurse that fills the pump.They were directed by the healthcare provider¿s office to contact the manufacturer and inquired if the pump could be checked remotely.The reporter noted that when the issues occurred, they didn't think of the pump then, and stated the patient might have had covid or food poisoning.The reporter was redirected to their healthcare provider to further address the issue.Additional information was received from the healthcare provider (hcp) indicated that at the time of refill the expected reservoir volume was 9 and the action reservoir volume was 30.A catheter dye study was performed and no flow was confirmed.A mri of the catheter was negative for any granulomas.The hcp suspected scar tissue or catheter obstruction; the cause was unknown.The patient was being weaned down and provided oral medication.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13118381
• MDR Text Key: 285940405
• Report Number: 3004209178-2021-19148
• 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: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 12/02/2021
• 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 Age: 76 YR
• Patient Sex: Male