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

Model Number 7427

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Seroma (2069); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 04/17/2007

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3986a, lot#: n092341, implanted: (b)(6) 2009, product type: lead; product id: 748940, serial#: (b)(4), implanted: (b)(6) 2009, product type: extension.Other relevant device(s) are: product id: 3986a, serial/lot#: (b)(4), ubd: 21-nov-2010, udi#: (b)(4); product id: 748940, serial/lot#: (b)(4), ubd: 05-feb-2012, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient's implantable neurostimulator (ins).Information was reported that the caller is asking if the lead could be cut as they want to remove the ins and extension, but do not want to touch the paddle portion of the lead.The hcp indicated that they are wanting to remove the patient's ins extension and remove much of the lead.The hcp reported that the patient is complaining of pain due to the presence of the system.The patient can no longer lay on her back due to the pain.The patient has not used the ins or therapy in over ten years.The hcp reported they tried programming multiple times and could not get coverage where the patient wanted it.It was noted that they could get coverage in the low back, but not the other areas.No further complications were reported.No additional patient symptoms were reported.Additional information was received from the patient.It was reported that the cause was thinning of the skin over battery causing battery to protrude, causing pain from fitting clothes and pain when lying on back.Battery removed initially.Fluid accumulation in pocket.Fluid aspirated. needed 2nd surgery.Wiring was left in, creating pain.Wiring in area of battery protruding.2nd surgery done to remove distal wiring in all 3 locations with caps placed on end.  subsequent follow up appt cancelled due to corona virus.  to date, still having pain and difficulty lying on back in area of battery pocket.Patient provided their weight information and stated that devices are explanted as well as distal wiring.No further complications were reported.

• Brand Name: SYNERGY
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10133696
• MDR Text Key: 196779518
• Report Number: 3004209178-2020-09973
• 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: Physician
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2008
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2020
• Date Device Manufactured: 02/15/2007
• 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: 62 YR
• Patient Weight: 67