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

Model Number	3708240
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2017
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 manufacturer representative.It was reported that the extension had a damaged shipping box and a damaged product box prior to implant.The sterility of the device was questionable.The extension was no used.There was no patient involvement.
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
Additional information was received from a manufacturer representative (rep) on 2017-apr-21.It was reported that the affected device was in their possession and they were waiting on instructions regarding where to send it.Also, the rep was waiting on instructions to see if any additional information was needed to send with the product.There were no further complications reported or anticipated.
Additional Manufacturer Narrative
Analysis of the extension (serial (b)(4)) found that the extension packaging was damaged.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.

• 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: 6511487
• Report Number: 2649622-2017-04875
• Device Sequence Number: 142645
• Product Code: LGW
• UDI-Device Identifier: 00643169272996
• UDI-Public: 00643169272996
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/30/2017

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: 03/15/2021
• Device Model Number: 3708240
• Device Catalogue Number: 3708240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 06/27/2017; 06/27/2017
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 05/03/2017; 06/06/2017; 06/30/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1