MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SINGLE 8 EXTENSION; SCS EXTENSION

Device Problem High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

The event date is unknown.Pma/510(k) # is unknown.The results/method and conclusion codes along with the investigation results will be provided in the final report.Concomitant medical products and therapy dates: model: 3662, scs ipg, therapy date: unknown, model: unknown, scs lead, therapy date: unknown.During processing of this complaint, attempts were made to obtain complete device information.

Event Description

Device 3 of 3.Reference mfr.Report#: 1627487-2019-11541; reference mfr.Report#: 1627487-2019-11542.It was later determined the patient's extension had also been explanted.

Manufacturer Narrative

The report of high impedance / loss of therapy was confirmed.Analysis of the returned lead extension found that all internal wires in the strain relief area were broken.These fractures are consistent with an overstress condition or sudden event the lead was subjected to while still in vivo.

Event Description

Device 3 of 3.Reference mfr.Report#: 1627487-2019-11541.Reference mfr.Report#: 1627487-2019-11542.

Manufacturer Narrative

Upon further review, the brand name was determined.

Event Description

Device 3 of 3 reference mfr.Report#: 1627487-2019-11541; reference mfr.Report#: 1627487-2019-11542.

• Brand Name: SINGLE 8 EXTENSION
• 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
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 9269478
• MDR Text Key: 164721896
• Report Number: 1627487-2019-12276
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Other