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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 Low Blood Pressure/ Hypotension (1914); Pain (1994); Tingling (2171); Cramp(s) (2193); Numbness (2415); Loss of consciousness (2418); Ambulation Difficulties (2544); Cognitive Changes (2551)
Event Date 09/28/2018
Event Type  Injury  
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 on (b)(6) 2018 regarding a patient receiving hydromorphone and bupivacaine (doses and concentrations unknown) via an implanted infusion pump. The indication for use was malignant pain. It was reported that on (b)(6) 2018 the patient reported numbness and tingling along the left side of his body resulting in difficulty walking/standing and urinary retention. The patient was started on urecholine and the plan was to change the concentration of medications at the next refill. On (b)(6) 2018 the patient reported intermittent altered mental status and worsening numbness following personal therapy manager (ptm) activations. The pump was reprogrammed and bupivacaine was decreased, hydromorphone was increased, and baclofen was added. On (b)(6) 2018 the patient reported an episode of blacking out and becoming unresponsive after the previous visit. The patient was transferred to the emergency department (ed) and treated for dehydration. They were unsure at the hospital if the change in medication contributed to this. After reviewing the programmer report from the previous visit including the bridge bolus, the provider thought the change in concentration could have led to the decreased blood pressure and the episode and also the numbness, tingling, and altered mental status following ptm activations. The event resulted in an unscheduled clinic or office visit. The event was ongoing. The etiology indicated the event was related to the device or therapy and was not related to the implant procedure. The event was related to the drug bupivacaine with an increase in dose noted as a contributing factor it was further confirmed that the unresponsiveness, low blood pressure, and hospitalization were thought to be caused by the change in it medication concentration. No further complications were reported or anticipated.
 
Manufacturer Narrative
Evaluation conclusion code does not apply. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product id 8781, serial# (b)(4), implanted: (b)(6) 2018. Product type catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from an hcp via a clinical study on 2019-jan-28. It was reported that on (b)(6) 2018 the plan was to revise the catheter secondary to pain at the catheter site. The patient also reported pain in the left shoulder which he thought could be attributed to the catheter location. The patient also reported feeling either pain relief, full body numbness, or stomach cramps following ptm activations. For the side effects, the patient was instructed to only request two boluses close together, not three or four. On (b)(6) 2018 the patient reported constant numbness and tingling, feeling unsteady on his feet, and altered mental status. On (b)(6) 2018 the catheter tip was repositioned to c3 which also resolved the side effects the patient had previously reported. The event resolved without sequelae on (b)(6) 2018.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from an hcp via a clinical study on (b)(6) 2019-. It was reported that the pump was delivering dilaudid (0. 5mg at 0. 74978mg/day) and bupivacaine (7. 1mg at 10. 64682 mg/day).
 
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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 Key8046517
MDR Text Key126397499
Report Number3004209178-2018-24865
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,Followup
Report Date 01/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/14/2019
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 Received01/30/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/20/2018
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: 11/07/2018 Patient Sequence Number: 1
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