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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Reaction (2414); Loss of consciousness (2418); Shaking/Tremors (2515)

Event Date 09/05/2016

Event Type  Injury  

Event Description

Information was received from a consumer regarding a patient who was receiving fentanyl at an unknown concentration at a dose of 175 mcg/day via an implantable pump for non-malignant pain.It was reported that the patient wanted a different medication in the pump and asked what she had to do to have that done.The patient stated that she thought the fentanyl was not agreeing with her body.The patient was admitted because she was passing out and her blood pressure would drop.These were considered reactions to the medication.The patient stated that while she was in the hospital a representative came and decreased the medication in half from 350 mcg/day to 175 mcg/day.The patient had felt like her whole insides were shaking and quivering starting 6-8 months ago (approximately (b)(6) 2016).The patient stated that her insides felt wrong.The reaction to the medication was stated to have started in (b)(6) 2017.The patient transferred hospitals and was released (b)(6) 2017.The patient was having problems with the pump then clarified that the pump was working fine, she was having issues with the medication.There were no out of box failures reported.There were no medical or therapy problems associated with small parts reported.Additional information was received from a healthcare provider (hcp) on 2017-may-08.It was unknown when the medication was decreased from 350 mcg/day to 175 mcg/day.It was done during the hospital stay.The diagnostics, actions, and interventions taken were the patient was taken off numerous medications in the hospital.The hcp was unsure of the diagnostic test performed.The cause of the passing out, blood pressure drop, and shaking was unknown.To the best of the hcp¿s knowledge, the patient symptoms have resolved.At the last visit, the patient stated their blood pressure was low, but the hcp did not read any low readings.The blood pressure readings from (b)(6) were 142/88, 126/75, and 147/86.It was stated that the patient¿s weight had fluctuated between 187 and 195 in the most recent office visits.The patient had requested multiple pain pump medication increases that the hcp had not advised.The patient also asked for other medications that the hospitalist had taken her off.The hcp had not increased this due to her complaints.Additional information was received from a manufacturer representative on 2017-may-15.The representative was asked to see the patient on (b)(6) 2017.They were instructed to decrease her daily dose from 350 mcg to 175 mcg.That was the first interaction the representative had with the patient and the first time that they heard she had any issue.They were unaware of the circumstances surrounding the hospitalization and unaware of her condition since (b)(6) 2017.A printed copy of the pump readout after this decrease was put in her chart and given to the hcp¿s office.There were no further complications reported.

Manufacturer Narrative

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

Event Description

Information was received from a consumer.It was reported the patient went to the emergency room (er) in april for something that had nothing to do with the pump.The patient was having heart issues.The patient¿s blood pressure would go low then high and she ended up having to go back on blood pressure medication.The dose of the medication in her pump was cut in half and she started having withdrawal symptoms.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): 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: 6574926
• MDR Text Key: 75425488
• Report Number: 3004209178-2017-10530
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/18/2017
• Supplement Dates Manufacturer Received: 04/11/2017; 09/22/2017
• Supplement Dates FDA Received: 09/25/2017; 09/26/2017
• Date Device Manufactured: 09/30/2015
• 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 Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 85