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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 Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Patient Problems Low Blood Pressure/ Hypotension (1914); Burning Sensation (2146); Complaint, Ill-Defined (2331); Low Oxygen Saturation (2477); Confusion/ Disorientation (2553)
Event Date 10/02/2019
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) regarding a patient receiving intrathecal dilaudid 10 mg/ml at 3. 195 mg/day via an implanted pump for non-malignant pain. The hcp suspected a pocket fill occurred. It was reported on 02-oct-2019 the patient had a refill and the procedure was unremarkable other than the pump was tilted some in the pocket. It was noted there was no volume discrepancy. It was noted just after the refill the patient complained of some burning to the pump pocket. The hcp sat with the patient for a short time and the symptoms improved. The patient left and about 20 minutes later the patient called her stating she was feeling "weird". The patient called 911 and was admitted to the hospital. The patient was worked up medically and oxygen saturation was a little low, hypotension, and some minor confusion. The patient was discharged from the hospital on (b)(6) 2019. The pump reservoir was aspirated and the expected residual volume was 39. 3 mls and the actual residual volume was 32. 5 mls. The hcp believed she did a partial pocket fill. The patient was doing well now. The change in therapy/symptoms was sudden. The event date was (b)(6) 2019. No further complications were reported/anticipated or expected.
 
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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 Key9210841
MDR Text Key173445754
Report Number3004209178-2019-19957
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
Report Date 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2016
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 Received10/07/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/01/2015
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: 10/18/2019 Patient Sequence Number: 1
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