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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE DRUG INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION IMPLANTABLE DRUG INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number NEU_UNKNOWN_PUMP
Device Problems Difficult to Advance (2920); Material Integrity Problem (2978)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/11/2021
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 14-may-2023, udi#: (b)(4), product type: catheter; product id: 8781, serial/lot #: (b)(4), ubd: 28-jun-2023, udi#: (b)(4), product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from foreign healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient with an implantable pump. On (b)(6) 2021, it was reported that the patient was having a catheter implanted. It was noted that, because the patient had a lumbar kyphosis, the placement of the catheter was difficult. While trying to manipulate the catheter to advance it along the spinal column, the hcp reported that the catheter broke 1 cm from the extremity of the catheter. The hcp attempted to implant a second catheter but the catheter broke at the same level. In the end, no catheter was implanted, but 2 pieces of catheter (1 cm each) were left in the spinal canal. The patient reportedly would not receive any tdd therapy. The issue was considered resolved. The patient's status was listed as "alive - no injury". Additional information was received from a foreign manufacturer's representative (rep) on 2021-oct-20. It was reported that no pump or catheter were implanted in the patient as the event happened during surgery.
 
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Brand NameIMPLANTABLE DRUG INFUSION PUMP
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12694318
MDR Text Key282841577
Report Number2182207-2021-01863
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNEU_UNKNOWN_PUMP
Device Catalogue NumberNEU_UNKNOWN_PUMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? Yes
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: 10/25/2021 Patient Sequence Number: 1
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