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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 8637-20
Device Problems Pumping Stopped (1503); Protective Measures Problem (3015)
Patient Problem Pain (1994)
Event Date 08/04/2018
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 device manufacturer representative regarding a patient receiving morphine(1 mg/ml, 0. 1 mg/day) via an implantable infusion pump for the treatment of non-malignant pain. It was reported that motor stall was seen at initial interrogation. There were multiple motor stalls and recoveries. Motor stalls first started to occur on (b)(6) 2018. It was confirmed that there was no emi/magnetic sources present. The patient experienced increase in pain which was considered as a sudden change in therapy/symptoms. Additional information was received from the consumer via a device manufacturer representative. It was reported that patient saw code 8478 (safe state in use) on personal therapy manager (ptm). The healthcare provider (hcp) did not plan on changing the pump out shortly. It was reported that the cause of safe state was unknown. Patient's weight was maybe around (b)(6). The surgery was scheduled on (b)(6) 2018. No further complication was reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Device was returned by the representative. Based on logs, 15 motor stalls occurred and 15 motor stalls occurred from (b)(6) 2018 at 09:15 to (b)(6) 2018 at 17:08. No further complication was reported.
 
Manufacturer Narrative
H3: the pump was returned and analysis identified electrochemical migration across the electrical feed-through insulator. 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7826654
MDR Text Key118560133
Report Number3004209178-2018-19410
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2015
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: 08/29/2018 Patient Sequence Number: 1
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