MAUDE Adverse Event Report: MPRI SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	977D260
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received via a manufacturing representative (rep) and healthcare provider (hcp) regarding a patient who was implanted with a neurostimulator (ins).Information was received that the md was having difficulty pulling the lead through needle canula.The lead was explanted.The md opened new lead.No further complications were reported.No patient symptoms were reported.
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received.The cause of the difficulty pulling the lead through the needle canal had not been determined and the representative reported no symptoms.No further complications reported.
Additional Manufacturer Narrative
Analysis identified that the needle was damaged at the distal end of the lead.The damage is consistent with field use.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7083083
• Report Number: 2649622-2017-12891
• Device Sequence Number: 19203192
• Product Code: LGW
• UDI-Device Identifier: 00643169118249
• UDI-Public: 00643169118249
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/04/2019

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: 11/17/2021
• Device Model Number: 977D260
• Device Catalogue Number: 977D260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 12/07/2017; 01/08/2018; 01/04/2019
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 12/08/2017; 02/02/2018; 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR