MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM; SCS LEAD

Model Number 3228

Device Problems Disconnection (1171); High impedance (1291)

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Date 06/14/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 1 of 2.Reference mfr.Report#: 1627487-2018-01725.It was reported the patient was not receiving stimulation coverage from the scs system.The patient also suffered a recent fall.Diagnostic testing revealed high impedance values on multiple lead contacts.X-rays revealed the lead has migrated and pulled out of the ipg header.As such, the patient may undergo surgical intervention to address the issues.

Manufacturer Narrative

Mfr.Report reference number is: 1627487-2018-07126 not 1627487-2018-01725 as previously reported.

Event Description

Device 1 of 2, reference mfr.Report#: 1627487-2018-07126.It was reported the patient underwent surgical intervention on (b)(6) 2018, wherein the same lead was relocated and reconnected to the same ipg.Reportedly, effective therapy resumed following the procedure.

• Brand Name: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS LEAD
• 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: jennifer shepard ; 6901 preston road; plano, TX 75024 ; 9725264657
• MDR Report Key: 7739336
• MDR Text Key: 115692948
• Report Number: 1627487-2018-07125
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067017253
• UDI-Public: 05415067017253
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2020
• Device Model Number: 3228
• Device Lot Number: 6273875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2018
• 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