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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 Fall (1848); Dizziness (2194); Cognitive Changes (2551); No Code Available (3191)
Event Date 06/13/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider via a clinical study reported the patient was receiving hydromorphone (0. 5 mg/ml at 0. 49981 mg/day) and bupivacaine (7. 1 mg/ml at 7. 0872 mg/day) via an implantable pump.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from healthcare provider (hcp) via clinical study indicated the cause of the hallucinations, light headedness, dizziness, dry mouth, and episodes of falling was due to therapy initiation. It was noted that the symptoms resolved with reprogramming. The patient's weight was not measured. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a clinical study regarding a patient receiving hydromorphone at an unknown concentration and dose via an implantable infusion pump. It was reported the patient reported dizziness and lightheadedness on (b)(6). The intrathecal rate was decreased in an effort to alleviate the symptoms. The patient was instructed to sit for 15-20 minutes following activating the personal therapy manager (ptm) to help prevent the dizziness and lightheadedness following ptm activations. The clinical diagnosis was intrathecal medication side effects. The outcome was ongoing. The etiology of the event was noted as related to the device or therapy and related to the drug hydromorphone with the drug action that caused the event being therapy initiation. Additional information received from a healthcare provider (hcp) via a clinical study indicated the outcome of the event resolved without sequelae on (b)(6). Interventions included the pump was reprogrammed on (b)(6). On (b)(6), the patient reported hallucinations and episodes of falling. On (b)(6) the patient reported dry mouth following personal therapy manager (ptm) activations. The intrathecal rate was decreased on (b)(6). The correct serial number was provided. Indication for use was spinal pain. No further complications were reported/anticipated.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6989153
MDR Text Key103207243
Report Number3004209178-2017-22806
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,study
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/06/2017
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: 10/30/2017 Patient Sequence Number: 1
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