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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD

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ABBOTT MEDICAL OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD Back to Search Results
Model Number 3186
Device Problems Battery Problem (2885); Migration (4003)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/26/2021
Event Type  Injury  
Manufacturer Narrative

Additional components involved in the event: product family: scs lead, model: 3186, udi: (b)(4), serial: (b)(4), batch: 5018273. Product family: scs ipg, model: 3660, udi: (b)(4), serial: (b)(4), batch: a000077060. A patient experienced ineffective stimulation due to lead migration was reported to abbott. As a result, the patient's had a lead replacement to address the issue. 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 event could not be conclusively determined. A patient¿s ipg reached end of service was reported to abbott. The ipg was explanted and replaced. The results of the investigation are inconclusive since the devices were not returned for analysis. Based on the information received, the cause of the reported event could not be conclusively determined.

 
Event Description

It was reported the patient experienced ineffective stimulation and an inoperable ipg. As a result, surgical intervention was undertaken wherein the system was explanted and replaced resolving the issues. The investigation did not determine which lead contributed to the inadequate pain relief.

 
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Brand NameOCTRODE LEAD KIT, 60CM LENGTH
Type of DevicePERCUTANEOUS LEAD
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key12393549
MDR Text Key268992352
Report Number1627487-2021-16673
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/31/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2017
Device MODEL Number3186
Device Catalogue Number3186
Device LOT Number5030688
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/26/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/28/2015
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: 08/31/2021 Patient Sequence Number: 1
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