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

Model Number	977D260
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via a manufacturer representative (rep) regarding advanced pain care trial leads.It was reported that the integrity of the lead was hindering lead placement.The leads appeared to be wavy and not straight.The wavy leads did not allow for good steering and lead placement.The leads were not implanted.All the leads with the same lot number for that account were going to be returned and replaced.No symptoms were reported.No further complications were reported as a result of this event.
Additional Manufacturer Narrative
Device lot was returned unopened to distribution with no indication of use.No method for the complainant to see the status of the leads in the box.The leads passed a 6 sided check and were restocked.A device history review was performed and it did not contain any findings related to the complaint.For the lead that was used in-vivo and resulted in the physician returning their unopened lot, see manufacturer¿s report #2649622-2017-04950.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: 6607481
• Report Number: 2649622-2017-04980
• Device Sequence Number: 1170707
• Product Code: LGW
• UDI-Device Identifier: 00643169118249
• UDI-Public: 00643169118249
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2017

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: 05/11/2021
• Device Model Number: 977D260
• Device Catalogue Number: 977D260
• Device Lot Number: VA1GTC1008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 11/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1