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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 Filling Problem (1233); Protective Measures Problem (3015)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2018
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 regarding a patient receiving hydromorphone, bupivacaine and baclofen, dose and concentrations not reported, via an implantable pump. The indications for use were not reported. On (b)(6) 2018 the healthcare provider reported they were filling the pump under fluoro in the or (operating room) and was able to aspirate the pump without difficulty but was only able to fill the pump half full. The healthcare provider then attempted to aspirate the contents of the reservoir and now it was locked. It was confirmed proper needle orientation and troubleshooting options were reviewed. There were no patient symptoms and no further complications were reported.
 
Event Description
Additional information was received from the consumer who reported that their pump was replaced because the healthcare provider was unable to fill it. Per the patient it was gradually getting harder to fill and then eventually the physician was able to remove the medication but not fill the reservoir.
 
Manufacturer Narrative
The initial mdr was filed as mfr report # 3007566237. Additional review indicated the correct manufacturing site is 3004209178. 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 MN 00777 1200
MDR Report Key7451112
MDR Text Key106180278
Report Number3007566237-2018-01197
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/23/2018 Patient Sequence Number: 1
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