MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 IPG; SCS IPG

Model Number	3667
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.
Event or Problem Description
It was reported the patient¿s ipg would not communicate.Patient underwent surgical intervention for unknown reasons, prior to the ipg being rendered inoperable, wherein electrocautery was used.The ipg was placed in surgery mode.In turn, surgical intervention was undertaken on (b)(6) 2019 wherein the ipg was explanted and replaced with a new ipg.Reportedly, therapy was restored postoperatively.
Additional Manufacturer Narrative
The reported issue of inoperable ipg was confirmed.As received, the device was not communicating; it was also noted the juno processor was in a stuck state.After manually clearing the stuck processor condition, the device was found to be in therapy app state.The, as received, condition of the ipg is consistent with the unrelated surgery that the patient reported having after which, the device no longer communicated.As a result of this finding, actions have been taken to prevent reoccurrence.

• Brand Name: PROCLAIM 7 IPG
• Common Device Name: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8424967
• Report Number: 1627487-2019-03431
• Device Sequence Number: 2170517
• Product Code: LGW
• UDI-Device Identifier: 05415067023254
• UDI-Public: 05415067023254
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2019
• Device Model Number: 3667
• Device Lot Number: 6145100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 06/05/2019; 10/31/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 06/14/2019; 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other