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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG Back to Search Results
Model Number 3660
Device Problem Battery Problem (2885)
Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)
Event Date 05/30/2022
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.
 
Event Description
It was reported that the patient received a message for ipg reaching end of life.As such, surgical intervention took place on (b)(6) 2022 wherein the ipg was explanted and replaced with a new ipg addressing the issue.Reportedly, therapy was restored post op.
 
Event Description
Additional information received indicates that the patient received the elective replacement indicator.
 
Manufacturer Narrative
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.
 
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Brand Name
PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key15019778
MDR Text Key295948305
Report Number3006705815-2022-15529
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067020192
UDI-Public05415067020192
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/15/2022
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? Yes
Device Operator Health Professional
Device Expiration Date06/20/2021
Device Model Number3660
Device Catalogue Number3660
Device Lot NumberA000082021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/27/2022
Initial Date FDA Received07/14/2022
Supplement Dates Manufacturer Received06/27/2022
Supplement Dates FDA Received07/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2019
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
SCS LEAD.
Patient Outcome(s) Other;
Patient SexFemale
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