MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE PRIME; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	37701
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	10/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other applicable components are: product id: 3093-28, lot#: va0mp87, implanted: (b)(6) 2014, product type: lead.Product id: 3093-28, lot#: va0lg0p, implanted: (b)(6) 2014, product type: lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer regarding an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient's leads were out of place and not connected and that the weren't receiving therapy since about 2 years ago.The patient was working with their doctor to have their ins and leads replaced.No further complications reported.

• Brand Name: RESTORE PRIME
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7935864
• Report Number: 3004209178-2018-22312
• Device Sequence Number: 770431
• Product Code: LGW
• UDI-Device Identifier: 00613994842299
• UDI-Public: 00613994842299
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2018

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: 01/28/2015
• Device Model Number: 37701
• Device Catalogue Number: 37701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/04/2018
• 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: 73 YR