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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 60CM; SCS EXTENSION
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ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 60CM; SCS EXTENSION Back to Search Results
Model Number 3346
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Impaired Healing (2378)
Event Date 11/29/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Device #2 of 3: reference mfr.Report:3006705815-2016-00692 and 1627487-2016-006497.It was reported the incision wounds had not healed properly and to minimize the risk of infection the patient underwent surgical intervention on (b)(6) 2016 to explant the ipg and the two extensions.
 
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Brand Name
EXTENSION, DUAL 4 CHANNEL 60CM
Type of Device
SCS EXTENSION
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key6187461
MDR Text Key62790052
Report Number1627487-2016-06496
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/13/2018
Device Model Number3346
Device Lot Number5459839
Was Device Available for Evaluation? No
Date Manufacturer Received11/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MODEL 3166 (2), PNS LEAD; MODEL 3169 (2), PNS LEAD
Patient Outcome(s) Other;
Patient Age56 YR
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