MAUDE Adverse Event Report: MPRI PISCES-QUAD; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 3888-33

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare professional via the manufacturer representative reporting at the end of the trial surgical procedure for lead placement, the surgeon wanted to connect the lead to the extension but the lead sheath became detached from the conductor cable.The surgical procedure lasted longer than usual because the patient bled a lot, which was probably caused by a small arteriole severed.To stop the bleeding the surgeon had to remove the first anchor that was placed around the lead, compressed the incision with gauze pads, and demanded the anesthetist to reduce the patient¿s blood pressure.The diagnostics/troubleshooting was performed, impedances were measured and were normal.The cause of the sheath becoming detached was unknown.The lead would have been replaced if the trial was successful, but the trial was not successful.The event resolved.The lead was explanted.The event resolved.

• Brand Name: PISCES-QUAD
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10519200
• MDR Text Key: 206473297
• Report Number: 2649622-2020-17438
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P840001
• 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
• Report Date: 09/10/2020

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 Date: 09/04/2023
• Device Model Number: 3888-33
• Device Catalogue Number: 3888-33
• Device Lot Number: VA227GB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/10/2020
• Date Device Manufactured: 09/04/2019
• 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): Required Intervention