MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: lead.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 Description

Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient had a lead issue.It was reported that one of the leads was not in the right spot.There was a revision performed on (b)(6).The call was made to inquire which kit contained the anchor removal tool.No further compilations were reported or anticipated.No symptoms were reported.

Manufacturer Narrative

Product id 977a260 serial# (b)(4) implanted: (b)(6)2017 explanted: (b)(6)2017 product type lead product id 977a260 serial#(b)(4) implanted: (b)(6)2017 explanted: (b)(6)2017 product type lead if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep reporting that the root cause was due to an anchoring issue.The rep stated that the leads had been replaced.No further compilations were reported or anticipated.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6731406
• MDR Text Key: 80641338
• Report Number: 3004209178-2017-15276
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2017
• Date Device Manufactured: 05/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR