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

Model Number	977C265
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative regarding a patient who was implanted with a neurostimulator on (b)(6) 2019.It was reported that the lead was placed and after doing an impedance check, electrodes 1 and 9 came back greater than 40,000 ohms.After doing multiple impedance checks and repositioning the lead in the wireless external neurostimulator, the lead was removed and replaced.Impedance on the new lead was within normal limits.There were no patient symptoms or complications reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a manufacturer representative who indicated that this was a staged trial.The patient¿s medical history includes chronic pain.There were no further complications reported or anticipated.
Additional Manufacturer Narrative
The returned device passed all testing in the laboratory and no anomalies were identified.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPECIFY SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8546246
• Report Number: 2649622-2019-06933
• Device Sequence Number: 14061169
• Product Code: LGW
• UDI-Device Identifier: 00643169464650
• UDI-Public: 00643169464650
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2022
• Device Model Number: 977C265
• Device Catalogue Number: 977C265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 04/19/2019; 08/01/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/02/2019; 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 113