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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Battery Problem (2885); Infusion or Flow Problem (2964)
Patient Problems Diarrhea (1811); Muscle Weakness (1967); Pain (1994); Dizziness (2194); Discomfort (2330); Shaking/Tremors (2515)
Event Date 09/28/2021
Event Type  Injury  
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving dilaudid (5 mg/ml at 1. 3217 mg/day) via an implanted pump. The patient¿s medical history was noted to be chronic back pain, history of non-hodgkin¿s lymphoma, and status post covid. The patient¿s concomitant medication was noted to be hydrocodone (5/325 tid). The indication for pump use was non-malignant pain. It was reported that the patient¿s pump had been replaced in september due to approaching eri (elective replacement indicator). The medication from the old pump was transferred to the new pump and the patient was scheduled for a refill in october. Per the patient, since the replacement, she never felt she had good pain relief as she had in the past with the pump. After the refill on (b)(6) 2021, she was feeling more discomfort and had increased pain. She saw her hcp on (b)(6) 2021 for her post-op appointment and he recommended that she have a catheter dye study. A dye study was attempted on (b)(6) 2021 but the hcp was unable to aspirate the catheter. The roller study was normal. An mri was also done to rule out a granuloma. According to the patient¿s son, a couple of hours after the dye study, the patient developed withdrawal symptoms. She started feeling dizzy, had diarrhea, and was shaky and weak and this went on for 5 days until they were able to get a hold of the hcp¿s office. The patient was then prescribed hydrocodone for the withdrawal symptoms. On (b)(6) 2022 the patient was taken to surgery for a pump replacement and possible catheter replacement. At the time of the pump replacement, since the expected reservoir volume was 14. 7 ml and the amount withdrawn from the old pump reservoir was 15 ml, the hcp determined that the catheter was infusing so decided to do a back table prime of the new pump. The catheter was not checked, revised, or explanted during the procedure. It remained intact and in use in the patient. It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue. The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.
 
Manufacturer Narrative
Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2002, product type: catheter. Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 19-jun-2004, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key13470682
MDR Text Key285154448
Report Number3004209178-2022-01666
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2020
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: 02/07/2022 Patient Sequence Number: 1
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