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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); Material Integrity Problem (2978)
Patient Problems Pain (1994); Ambulation Difficulties (2544); Insufficient Information (4580)
Event Date 12/04/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2022, product type: catheter. Other relevant device(s) are: product id: 8598a, serial/lot #: (b)(4), ubd: 05-may-2018, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving compounded baclofen (unknown dose and concentration), hydromorphone (unknown dose and concentration), bupivacaine (unknown dose and concentration), and clonidine (unknown dose and concentration) via an implantable pump. It was reported on (b)(6) 2021 the hcp received a message that the patient reported an new pain (onset (b)(6) 2021) in their spine resulting in immobility. The patient described the pain as grinding. After contacting emt, the patient was transferred to the ed (emergency department) where a ct (computed tomography) scan was unremarkable. The pain had since subsided but returns intermittently. The patient was scheduled for a next-day office visit. On (b)(6) 2021 it was noted the pain worsens when sitting or standing; but improves when supine. The patient was started on percocet, administered a toradol injection, and an mri (magnetic resonance imaging) was ordered. On (b)(6) 2021 a cap (catheter access port) dye study revealed the catheter migrated from t3 to t10 dorsal, left of midline. It was also coiled near the cap port in the right flank, likely causing the acute pain. The plan was for a catheter revision. It was noted that minimal csf (cerebrospinal fluid) was aspirated. On (b)(6) 2022 surgical intervention occurred where the catheter was spliced and the spinal segment was replaced and tip positioned at t4. The outcome of the event resolved without sequelae on (b)(6) 2022. The device diagnosis was other catheter coiled neat catheter access port and catheter dislodgement. The clinical diagnosis was new region/quality of pain in spine. The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13258160
MDR Text Key284168301
Report Number3004209178-2022-00649
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 Study,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 01/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/06/2017
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: 01/14/2022 Patient Sequence Number: 1
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