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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KIT IMPLANTABLE SLIM TIP LEAD, 50CM; DRG SLIM TIP LEAD
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KIT IMPLANTABLE SLIM TIP LEAD, 50CM; DRG SLIM TIP LEAD Back to Search Results
Model Number MN10450-50A
Medical Device Problem Code Impedance Problem (2950)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 10/13/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
Related manufacturer report number: 1627487-2021-18048, 1627487-2021-18051.It was reported that the patient was experiencing ineffective therapy.Reprogramming was unable to resolve the issue.As a result, the patient underwent surgical intervention during which the leads were replaced and effective therapy was established post-operatively.
 
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Brand Name
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
Common Device Name
DRG SLIM TIP LEAD
MDR Report Key12733063
Report Number1627487-2021-18049
Device Sequence Number1631870
Product Code PMP
UDI-Device Identifier05415067027153
UDI-Public05415067027153
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P150004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date01/12/2022
Device Model NumberMN10450-50A
Device Catalogue NumberMN10450-50A
Device Lot Number7333911
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/13/2021
Initial Report FDA Received Date11/01/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured01/13/2020
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age51 YR
Patient Weight70
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