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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 Problem Difficult to Insert (1316)
Patient Problems Cerebrospinal Fluid Leakage (1772); Swelling (2091); Headache, Lumbar Puncture (2186)
Event Date 08/24/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_cath, serial# unknown, product type: catheter. Product id: neu_unknown_cath, serial/lot #: unknown. 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 dilaudid(0. 2 mg/day, 2 mg/ml) via an implantable infusion pump. The patient was a smoker. It was reported that the patient had developed headache approximately 3 weeks after pain pump was implanted. On (b)(6) 2018, it was noticed that he had some swelling at the base of the spinal scar. A binder was applied. A blood patch was done that seemed to help with the spinal headache. On (b)(6) 2018, headache returned and on (b)(6) 2018 headache got worse. In the er, it was noticed that he had a clear liquid coming out of the apex of the spinal scar. The healthcare provider (hcp) decided to take patient to surgery. When spinal scar was opened clear fluid was coming out from around the catheter insertion site. The healthcare provider (hcp) removed the spinal catheter up to the anchor, which was 25 cm of catheter from the intrathecal space. The anchor remained in place to be able to easily find catheter. The patient referred to neurosurgeon for repair of possible dural tear and reinsertion of the pump catheter into the intrathecal space. Incision was closed until neurosurgeon is able to see patient and schedule surgery. Time and day of surgery was unknown at this time. Pump was at minimum rate and the patient was admitted to hospital. Difficulty of inserting spinal needle at time of pain pump implant may have contributed to spinal leak. The issue was resolved and patient status was alive with no injury at the time of the report. No further complication was reported.
 
Manufacturer Narrative
Product id: neu_unknown_cath, serial# unknown, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a device manufacturer representative indicated that they went in and added the new spinal segment (8782- 42. 4 cm). The caller required assistance with programming the catheter information. No further complications have been 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 Key7898417
MDR Text Key121047347
Report Number3004209178-2018-21251
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
Report Date 12/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2019
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received12/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/25/2018
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: 09/21/2018 Patient Sequence Number: 1
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