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

Model Number 977C165

Device Problem Impedance Problem (2950)

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

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacturer representative (rep) regarding an implantable neurostimulator (ins) lead.It was reported that there was an impedance issue on the lead.The rep took the lead out of the battery multiple times, wiped the contacts down, re-inserted the lead and the same 2 electrodes kept showing impedance issues.The lead ports in the battery were switched and the same 1 electrode showed impedance issues.The lead was replaced and the issue was resolved.The lead was expected to be returned for analysis.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPECIFY SURESCAN
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8977507
• MDR Text Key: 156985493
• Report Number: 2649622-2019-16225
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169464599
• UDI-Public: 00643169464599
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2023
• Device Model Number: 977C165
• Device Catalogue Number: 977C165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2019
• 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