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

Model Number 3888-56

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from the manufacturer representative reporting that during the trial procedure, the protective cap for connecting the lead with the extension was missing for the 56 electrodes.The action taken to resolve was the protective cap/tube from another lead was used.The patient was not impacted.

• 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: 10391654
• MDR Text Key: 202403527
• Report Number: 2649622-2020-15269
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2024
• Device Model Number: 3888-56
• Device Catalogue Number: 3888-56
• Device Lot Number: VA26QC2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Date Device Manufactured: 03/26/2020
• 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