MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNERGY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7427

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331); Injury (2348); Depression (2361); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 7496-51, serial# (b)(4), implanted: (b)(6) 1998, product type: extension.(b)(6).

Event Description

Information was received from a legal representative of the patient regarding a patient implanted with an implantable neurostimulator (ins).It was reported that the device caused iatrogenic leg pain.The ins and extension were explanted.The issue was not resolved at the time of this report.The patient was alive with injury.No further complications were reported or anticipated.

Manufacturer Narrative

Additional review determined the following device code is no longer related to this event: (b)(4).

Event Description

Additional information received from the manufacturing representative reported that the patient¿s pain was worse following explant.The system was no longer functioning and the physician wanted to explant all of the device to allow mris.No further actions or interventions were planned or performed at this stage.Since the patient had the stimulator removed they have suffered from ongoing acute pain.It was hypothesized by those treating the patient that the cause of the pain was the removal of the device¿s lead which intimately involved with such nerves.The patient was concerned that the leads should have been left in situ with only the battery being removed.The patient was extremely depressed and was unable to use his prosthesis and walk.The patient¿s ability to work and self care are affected.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, serial# unknown, 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

Additional information was received from a manufacturer representative reporting that the system (including the lead) was explanted as it was no longer working.The patient reported that the physical interaction of the lead with their body was causing pain and discomfort.Leg and groin pain was made worse with explant.The event occurred at the time of/following explant.No further actions or interventions were performed to resolve the issue.The patient¿s issues were not resolved, but there was nothing more that could be done now.

Manufacturer Narrative

Review determined product problem and adverse event.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.

Manufacturer Narrative

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

Event Description

Additional information reported the patient¿s system was explanted on (b)(6) 2016.It was noted the patient¿s lead was ¿possibly¿ a 3987 model that it was ¿possibly¿ implanted on (b)(6) 1998; further lead details were ¿otherwise unknown.¿.

Manufacturer Narrative

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

• Brand Name: SYNERGY
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6639915
• MDR Text Key: 77532376
• Report Number: 3007566237-2017-02358
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/10/2017

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 Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/12/2017; 07/12/2017; 07/12/2017
• Supplement Dates FDA Received: 06/19/2017; 06/28/2017; 07/06/2017; 08/10/2017; 09/07/2017
• 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