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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Nerve Damage (1979); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/06/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (healthcare provider (hcp), clinical study) regarding a patient who was receiving fentanyl (unknown dose and concentration) and bupivacaine (unknown dose and concentration) via an implantable pump for unknown indications for use. It was reported that  on (b)(6) 2021 the patient was experiencing increased generalized pain status post procedure.   on (b)(6) 2021 oxycodone-acetaminophen 5-325 mg was prescribed.   the patient was to take 1 to 2 tablets every 4 to 6 hours for post-surgical pain.   on (b)(6) 2021 oxycodone-acetaminophen 5-325 mg was prescribed for up to 5 times per day for severe pain.   the outcome was noted as ongoing.   the clinical diagnosis was unspecified abdominal pain.   the etiology of the event indicated the relationship of the event to the device or therapy was not related and indicated the relationship of the event to the implant procedure was possibly related (surgery/anesthesia). The event date was (b)(6) 2021. Additional information received from a healthcare professional (hcp) via a clinical study reported the patient called after hours on (b)(6) 2021 to report inadequate pain relief. Call from the hospital on (b)(6) 2021 indicated the patient went to the emergency room for all over body pain. The treating hcp ordered an mri (magnetic resonance imaging) to evaluate for nerve damage. The mri was inconclusive due to claustrophobia. The patient had a follow up on (b)(6) 2021 for post-op evaluation. No action was taken. The event date was updated to (b)(6) 2021. The clinical diagnosis was updated to inadequate pain relief.
 
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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 Key12820302
MDR Text Key280825867
Report Number3004209178-2021-17091
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 Study,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/13/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/11/2021
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: 11/16/2021 Patient Sequence Number: 1
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