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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 Migration or Expulsion of Device (1395); Material Separation (1562); Failure to Disconnect (2541); Material Integrity Problem (2978); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 05/24/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: catheter; product id: 8590-1, lot# n781832, implanted: (b)(6) 2018, product type: accessory. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4); product id: 8590-1, serial/lot #: n781832, ubd: (b)(6) 2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was provided by a healthcare provider via a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver dilaudid [1000 mcg/ml] at 121 mcg/day, indicated for non-malignant pain and failed back surgery syndrome. It was reported that the patient¿s pump was moving in the pocket. The event date was asked but would not be made available due to a legal/confidential reason. It was indicated that there were no environmental, external, or patient factors that may have led or contributed to the issue. The physician met with the patient in the office and observed that the pump was moving in the pocket. As an action/intervention taken to resolve the issue, a pocket revision was scheduled. Surgical intervention occurred. The case was scheduled as pocket revision. The pump appeared to be flipping in the pocket. The physician opened up the pocket and the mesh pouch was not adhered to the tissue and the catheter was twisted many times. The physician removed the sutureless pump connector, and it separated into two pieces. The catheter was partially explanted on (b)(6) 2018. It was reported that the catheter had a piece sheared near the connection and the proximal catheter was replaced. The issue was resolved at the time of the report and the patient's status was listed as ¿alive ¿ no injury. ¿ no patient symptoms were reported. The patient¿s medical history and weight were asked but would not be made available due to a legal/confidential reason. Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturing representative (rep). It was reported the rep was in possession of the explanted catheter segment and planned to return the piece to the manufacturer.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer representative and a healthcare professional (hcp) via a clinical study indicated the device diagnosis was pump inversion. The outcome of the event was noted as ongoing. (please note: this conflicts with the previously reported information that the issue was resolved. ) 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. No further complications were reported.
 
Manufacturer Narrative
The catheter was returned, and analysis found damage to the transition tube. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturing representative (rep). It was reported the doctor revised the pump segment of the catheter and the pump remains implanted. The rep did not know if the explanted portion of the catheter would be available for return at the time of the report (2018(b)(4).
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via a clinical study indicated a revision of the pump pocket occurred on 2018(b)(6). No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via a clinical study indicated the outcome of the event resolved without sequelae on (b)(6) 2018. No further complications were reported.
 
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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 Key7686884
MDR Text Key113952916
Report Number3004209178-2018-15737
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,Followup,Followup
Report Date 05/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2018
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: 07/13/2018 Patient Sequence Number: 1
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