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

Model Number 97702

Device Problems Device Or Device Fragments Location Unknown (2590); Malposition of Device (2616); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2014, product type: lead.Date inaccurate, only the month and year are valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient's ins was leaking in (b)(6) 2018 and their healthcare professional removed the ins in (b)(6) 2018.The patient noted that their healthcare provider clipped off the lead and it was still in their body.No further complications reported.

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.

Event Description

Additional information was reported that the patient was asked to clarify that their ins was leaking.The patient stated "that was the battery that leaked.The doctor felt the rest is in my body and those wires".The patient thinks that the circumstances that led to their ins leaking was their ins was not deep enough under their skin.The patient's ins leaking has been resolved, but the rest is still in the patient's body.The patient is going back in august to be checked.When the patient was asked for their weight, they responded with "poke me and brake the skin open".No further information was reported.

Manufacturer Narrative

Concomitant medical products: product id 39565-65, serial# (b)(4) implanted: (b)(6) 2014, product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the consumer.It was reported that the device was under the skin and they had the wires still in their body.They poked them and they had a place where "it was still leaking" from their back.The issue wasn't resolved yet but on (b)(6) 2018 they had to have surgery to get the rest of the stimulator out.No further complications reported.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7655098
• MDR Text Key: 112885318
• Report Number: 3004209178-2018-14764
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 07/23/2018; 08/06/2018; 08/08/2018
• Supplement Dates FDA Received: 08/01/2018; 08/15/2018; 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 77