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

Model Number 7427

Device Problems Migration or Expulsion of Device (1395); Low Battery (2584)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331); Skin Inflammation (2443)

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product type programmer, patient; product id 3487a-56, lot # j0219965v, implanted: (b)(6) 2002, product type lead; product id 7495lz40, serial# (b)(4), implanted: (b)(6) 2002, product type extension; product id 3487a-56; lot # j0219965v, implanted: (b)(6) 2002, product type lead; product id 7495lz40, serial # (b)(4), implanted: (b)(6) 2002, product type extension.

Event Description

A consumer implanted for other chronic/intract pain (trunk/limbs) and occipital neuralgia reported the implantable neurostimulator (ins) was loose and moving around in the pocket.It was noted there was no known accident or indicated related to this issue.The consumer believed it was pinching a nerve and there was a purple blood blister near the bottom of the ins and they pinched their hip on a rolling office chair four times yesterday.It was noted the ins battery had been dead for 5 years.The consumer continued to have concerns with their device or therapy but had not sought further help due to needing to find a new physician.It was noted the consumer was in desperate need of assistance.On march 14, 2016 additional information received from the healthcare provider (hcp) reported the consumer¿s device hadn¿t been on since 2002.The consumer additionally reported that at least once a year the implantable neurostimulator (ins) would catch on something, which hurt and if they tried to fit through an area about the size of their body the ins might catch on edges and pull.The consumer was fine with this, as ¿it was just something that happened.¿ it was noted the consumer was looking into replacing the ins, as it had been dead for six to eight years.According to the consumer nothing else had worked for their pain.Initially the ins didn¿t take away the pain, but it did help with the pain which showed the ins was a helpful therapy.

Manufacturer Narrative

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 received from the patient.The patient was not entirely sure of their weight at the time of the event, but they believed it was around (b)(6).The patient noted that it hadn't changed much.The patient planned on following up with another doctor.No further complications are anticipated.

Manufacturer Narrative

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 patient on 2017-may-12.The patient stated that their implant has been dead for over 8 years or more.They would like to get it replaced but needs their insurance company to okay it.It was reviewed that the patient should follow up with their healthcare professional (hcp) regarding a replacement and insurance inquiries.No further complications were reported.

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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5550851
• MDR Text Key: 41975391
• Report Number: 3004209178-2016-06155
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2003
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2017
• Date Device Manufactured: 05/08/2002
• 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 Weight: 68