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

Model Number 7427

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); No Device Output (1435); Unable to Obtain Readings (1516); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 08/01/2016

Event Type  Injury  

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with a neurostimulator.It was reported that the patient attempted to turn on the implantable neurostimulator (ins) last week and could not.The manufacturer representative interrogated the ins on (b)(6) 2016 with the clinician programmer and got the message that a reset occurred and the serial number was gone.The session was able to be continued and the battery information was run.The voltage was 2.52v and capacity used was 45-90%.Impedances at both 1.5v and 3v were run and ¿???¿ were seen at the combinations 0/4, 0/5, 1/5, 2/3, and 3/5.The patient reported no falls or traumas but they had started low impact aerobics and yoga in (b)(6).The patient had recent exposure to security gates and theft detectors in the airport security sometime in (b)(6).The manufacturer representative did threshold testing with the patient, activating most of the electrodes.However, when this was done the voltage was at 10.5v and the patient was not feeling anything except a zinging in their knee.The patient felt a zinging sensation in their ankle during impedance testing.The last time the patient felt stimulation normally was in (b)(6).Impedances were checked several more times with the ¿???¿ continuing to show up on several combinations.The measurement for 4-7 was showing 70 ohms.Prior to one of the impedance tests a power on reset was seen, prompting the manufacturer representative to enter the serial number.The manufacturer representative entered the serial number into the clinician programmer and ran impedances again with 4v obtaining the following results: 0-1 at ???, 0-2 at 529, 0-3 at ???, 0-4 at ???, 0-5 at 2084, 0-6 at 671, 0-7 at 735, 1-2 at 1176, 1-3 at 1171, 1-4 at 1661, 1-5 at 2787, 1-6 at 1661, 1-7 at 1661, 2-3 at 529, 2-4 at 907, 2-5 at 2084, 2-6 at 813, 2-7 at 907, 3-4 at 671, 3-5 at 2084, 3-6 at 671, 3-7 at 2084, 4-5 at 1661, 4-6 at 813, 4-7 at 104, 5-6 at ???, 5-7 at 1661, and 6-7 at 735.The manufacturer representative tested 2-3 combinations with 210 pulse width and 30 rate.At 4.4v the patient started to feel it but it was ¿static-y¿ and not normal like it had been.The patient was previously programmed on electrodes 0-3 and 4-7 for programs 1 and 2.It was reported that the patient was reprogrammed using the contacts that were within range.The patient had discussed lead revision/replacement with the health care professional (hcp).

Event Description

Additional information was received in a patient letter on (b)(6) 2016 reporting that the zinging sensation had not resolved.A manufacturer representative tried to reboot but it did not work.The system was going to be replaced on (b)(6) 2016.

Event Description

Additional information received from the manufacturer¿s representative reported that the patient was having the ins replaced on monday ((b)(6) 2017) due to what was believed as normal battery depletion.The representative mentioned the previous impedance issues and did not think the patient used the device that often.There was no new information other than the scheduled replacement of the device.

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 SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5922722
• MDR Text Key: 53795760
• Report Number: 6000032-2016-00118
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/14/2017

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 Expiration Date: 08/28/2002
• 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: 08/10/2016
• Initial Date FDA Received: 09/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 02/10/2017
• Supplement Dates FDA Received: 11/14/2016; 02/14/2017; 09/29/2017
• Date Device Manufactured: 03/13/2001
• 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: 66 YR