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

Model Number 37712

Device Problems Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3708140, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Other relevant device(s) are: product id: 3708140, serial/lot #: (b)(4).(b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) via a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for complex regular pain syndrome type i.The patient¿s medical history includes crps, htn, and depression.The patient was taken into surgery for an ins replacement.During the dissection of the battery pocket, the extension was cut.The hcp made the decision to plug and implant the new battery and wake the patient up to discuss the need for a more extensive revision to be undertaken on a future date.The issue was not resolved but the patient was noted to be alive with no injury.No further complications were reported/are anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacture representative (rep) on 2018-jul-02.The ins was replaced due to normal end of life (eol).The ins was discarded by the customer.The extension is remaining in the patient and the next revision surgery has not yet been scheduled.The cause of the healthcare professional (hcp) cutting the extension was due to the surgery.No further complications were reported/are anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESTORE ULTRA
• 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: 7656062
• MDR Text Key: 112947480
• Report Number: 3004209178-2018-14818
• Device Sequence Number: 1
• Product Code: LGW
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2009
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 09/03/2008
• 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: 67 YR