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

Model Number 97714

Device Problems High impedance (1291); Migration or Expulsion of Device (1395); Unable to Obtain Readings (1516); Impedance Problem (2950)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 977a160, serial#: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding an implantable neurostimulator (ins).It was reported that the patient described decreased efficacy of the device.The impedances were out of range >10000 when interrogated preoperation.All contacts were noted out of range.The leads and ins were replaced and the issues resolved.No further complications were reported or anticipated.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 977a160 (b)(4) implanted: (b)(6)2014 explanted: (b)(6)2018 product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the representative.It was reported that the affected devices would not be returned to the manufacturer for analysis- the customer cut the leads and discarded them.The leads did not appear to have migrated, per the x-ray, but were replaced due to impedance issues.This information was confirmed with the physician.No further complications reported.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 977a160 lot# serial# (b)(4) implanted: 2014 (b)(6) explanted: 2018 (b)(6) product type lead product id 977a160 lot# serial# (b)(4) implanted: 2014 (b)(6) explanted: 2018 (b)(6) product type lead conclusion code 92 applies to the ins and conclusion code 22 applies to the lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative.It was reported that the patient was getting a revision due to lead migration.During a pre-op impedance test, electrode 13 had impedance values higher than 10,000 ohms and ¿xxx¿ values were displayed for all other contacts.The manufacturer representative stated that the entire system was replaced at the physician¿s request.No further complications were reported or anticipated.

• Brand Name: SURESCAN
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7306570
• MDR Text Key: 101281808
• Report Number: 3004209178-2018-04258
• Device Sequence Number: 1
• Product Code: LGW
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2018
• Date Device Manufactured: 12/17/2013
• 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: 49 YR